-
1
-
-
0035070215
-
The role of modelling and simulation in phase I drug development
-
and Invited COST B15 Experts
-
Aarons, L., Karlsson, M., Mentre, F., Rombout, F., Steimer, J.-L., van Peer, A., and Invited COST B15 Experts (2001) The role of modelling and simulation in phase I drug development. European Journal of Pharmaceutical Sciences, 13, 115-122.
-
(2001)
European Journal of Pharmaceutical Sciences
, vol.13
, pp. 115-122
-
-
Aarons, L.1
Karlsson, M.2
Mentre, F.3
Rombout, F.4
Steimer, J.-L.5
van Peer, A.6
-
2
-
-
0000501656
-
Information theory and an extension of the maximum likelihood principle
-
Akaike, H. (1973) Information theory and an extension of the maximum likelihood principle. Second International Symposium on Information Theory, 267-281.
-
(1973)
Second International Symposium on Information Theory
, pp. 267-281
-
-
Akaike, H.1
-
3
-
-
0000004140
-
Measurement in medicine: The analysis of method comparison studies
-
Altman, D.G., Bland, J.M. (1983) Measurement in medicine: the analysis of method comparison studies. The Statistician, 32, 307-317.
-
(1983)
The Statistician
, vol.32
, pp. 307-317
-
-
Altman, D.G.1
Bland, J.M.2
-
4
-
-
84971580244
-
Absence of evidence is not evidence of absence
-
Altman, D.G., Bland, J.M. (1995) Absence of evidence is not evidence of absence. British Medical Journal, 311, 485.
-
(1995)
British Medical Journal
, vol.311
, pp. 485
-
-
Altman, D.G.1
Bland, J.M.2
-
5
-
-
1542316304
-
Torsades de pointes associated with fluoroquinilones: Importance of concommitant risk factors
-
Amankwa, A., Krishnan, S., Tisdale, J. (2004) Torsades de pointes associated with fluoroquinilones: importance of concommitant risk factors. Clinical Pharmacology and Therapeutics, 75(3), 242-7.
-
(2004)
Clinical Pharmacology and Therapeutics
, vol.75
, Issue.3
, pp. 242-247
-
-
Amankwa, A.1
Krishnan, S.2
Tisdale, J.3
-
6
-
-
0002211607
-
Individual bioequivalence: A problem of switchability [with discussion]
-
Anderson, S. (1993) Individual bioequivalence: a problem of switchability [with discussion]. Biopharmaceutical Reports, 2, 1-11.
-
(1993)
Biopharmaceutical Reports
, vol.2
, pp. 1-11
-
-
Anderson, S.1
-
7
-
-
0029150560
-
Current issues in individual bioequivalence
-
Anderson, S. (1995) Current issues in individual bioequivalence. Drug Information Journal, 29, 961-964.
-
(1995)
Drug Information Journal
, vol.29
, pp. 961-964
-
-
Anderson, S.1
-
8
-
-
84947888949
-
A new procedure for testing equivalence in comparative bioavailability and other clinical trials
-
Anderson, S., Hauck W.W. (1983) A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Communications in Statistical Theory and Methods, 12, 2663-2692.
-
(1983)
Communications in Statistical Theory and Methods
, vol.12
, pp. 2663-2692
-
-
Anderson, S.1
Hauck, W.W.2
-
11
-
-
0025966823
-
Interchangeability of low dose oral contraceptives
-
Ansbacher, R. (1990) Interchangeability of low dose oral contraceptives. Contraception, 43, 139-147.
-
(1990)
Contraception
, vol.43
, pp. 139-147
-
-
Ansbacher, R.1
-
12
-
-
4243273124
-
-
Academic Press, San Diego
-
Atkinson, A., Daniels, C., Dedrick, R., Grudzinskas, C., Markey, S., eds. (2001) Principles of Clinical Pharmacology. Academic Press, San Diego.
-
(2001)
Principles of Clinical Pharmacology.
-
-
Atkinson, A.1
Daniels, C.2
Dedrick, R.3
Grudzinskas, C.4
Markey, S.5
-
14
-
-
0002604165
-
A comparative study of various tests for the equality of two population variances
-
Balakrishnan, N., Ma, C.W. (1990) A comparative study of various tests for the equality of two population variances. Journal of Statistical Computing and Simulation, 35, 41-89.
-
(1990)
Journal of Statistical Computing and Simulation
, vol.35
, pp. 41-89
-
-
Balakrishnan, N.1
Ma, C.W.2
-
16
-
-
33746391404
-
Bayes factors for Fieller’s problem
-
Barbieri M.M., Liseo, B., Petrella, L. (2000) Bayes factors for Fieller’s problem. Biometrika, 87, 717-723.
-
(2000)
Biometrika
, vol.87
, pp. 717-723
-
-
Barbieri, M.M.1
Liseo, B.2
Petrella, L.3
-
17
-
-
0033667817
-
PhRMA perspective on population and individual bioequivalence and update to the PhRMA perspective on population and individual bioequivalence
-
Barrett, J.S., Batra, V., Chow, A., Cook, J., Gould, A.L., Heller, A., Lo, M.-W., Patterson, S.D., Smith, B.P., Stritar, J.A., Vega, J.M., Zariffa, N. (2000) PhRMA perspective on population and individual bioequivalence and update to the PhRMA perspective on population and individual bioequivalence. Journal of Clinical Pharmacology, 40, 561-572.
-
(2000)
Journal of Clinical Pharmacology
, vol.40
, pp. 561-572
-
-
Barrett, J.S.1
Batra, V.2
Chow, A.3
Cook, J.4
Gould, A.L.5
Heller, A.6
Lo, M.-W.7
Patterson, S.D.8
Smith, B.P.9
Stritar, J.A.10
Vega, J.M.11
Zariffa, N.12
-
19
-
-
0031917671
-
Why rate of absorption inferences in single dose bioequivalence studies are often inappropriate
-
Basson, R.P., Ghosh, A., Cerimele, B.J., DeSante, K.A., Howey, D.C. (1998)Why rate of absorption inferences in single dose bioequivalence studies are often inappropriate. Pharmaceutical Research, 15, 276-279.
-
(1998)
Pharmaceutical Research
, vol.15
, pp. 276-279
-
-
Basson, R.P.1
Ghosh, A.2
Cerimele, B.J.3
DeSante, K.A.4
Howey, D.C.5
-
20
-
-
0025805329
-
Multiple testing in clinical trials
-
Bauer, P. (1991) Multiple testing in clinical trials. Statistics in Medicine, 10, 871-890.
-
(1991)
Statistics in Medicine
, vol.10
, pp. 871-890
-
-
Bauer, P.1
-
21
-
-
84985727620
-
Testing equivalence simultaneously for location and dispersion of two normally distributed populations
-
Bauer, P., Bauer, M.M. (1994) Testing equivalence simultaneously for location and dispersion of two normally distributed populations. Biometrical Journal, 6, 643-660.
-
(1994)
Biometrical Journal
, vol.6
, pp. 643-660
-
-
Bauer, P.1
Bauer, M.M.2
-
22
-
-
0001499307
-
A unifying approach for confidence intervals and testing of equivalence and difference
-
Bauer, P., Kieser, M. (1996) A unifying approach for confidence intervals and testing of equivalence and difference. Biometrika, 83, 934-937.
-
(1996)
Biometrika
, vol.83
, pp. 934-937
-
-
Bauer, P.1
Kieser, M.2
-
23
-
-
0001127258
-
An analysis of time relations of electrocardiograms
-
Bazett, H. (1920) An analysis of time relations of electrocardiograms. Heart, 7, 353-367.
-
(1920)
Heart
, vol.7
, pp. 353-367
-
-
Bazett, H.1
-
24
-
-
0033306850
-
Bioequivalence of 1 and 5 mg Tacrolimus capsules using a replicate study design
-
Bekersky, I., Dressler, D., Colburn, W., Mekki, Q. (1999) Bioequivalence of 1 and 5 mg Tacrolimus capsules using a replicate study design. Journal of Clinical Pharmacology, 39, 1032-1037.
-
(1999)
Journal of Clinical Pharmacology
, vol.39
, pp. 1032-1037
-
-
Bekersky, I.1
Dressler, D.2
Colburn, W.3
Mekki, Q.4
-
25
-
-
0000767465
-
A nonparametric approach to the analysis of three-treatment three-period cross-over data
-
Bellavance, F., Tardif, S. (1995) A nonparametric approach to the analysis of three-treatment three-period cross-over data. Biometrika, 82, 865-875.
-
(1995)
Biometrika
, vol.82
, pp. 865-875
-
-
Bellavance, F.1
Tardif, S.2
-
26
-
-
0029026110
-
Bioequivalence and narrow therapeutic index drugs
-
Benet, L.Z., Goyan, J.E. (1995) Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy, 15, 433-440.
-
(1995)
Pharmacotherapy
, vol.15
, pp. 433-440
-
-
Benet, L.Z.1
Goyan, J.E.2
-
27
-
-
0032914001
-
Understanding bioequivalence testing
-
Benet, L.Z. (1999) Understanding bioequivalence testing. Transplantation Proceedings, 31, Suppl A, 7S-9S.
-
(1999)
Transplantation Proceedings
, vol.31
, pp. 7S-9S
-
-
Benet, L.Z.1
-
28
-
-
84919436881
-
Multiparametric hypothesis testing and acceptance sampling
-
Berger, R.L. (1992) Multiparametric hypothesis testing and acceptance sampling. Technometrics, 24, 295-300.
-
(1992)
Technometrics
, vol.24
, pp. 295-300
-
-
Berger, R.L.1
-
29
-
-
0043005476
-
Bioequivalence trials, intersection- union tests, and equivalence confidence sets
-
Berger, R.L., Hsu, J.C. (1996) Bioequivalence trials, intersection- union tests, and equivalence confidence sets. Statistical Science, 11, 283-319.
-
(1996)
Statistical Science
, vol.11
, pp. 283-319
-
-
Berger, R.L.1
Hsu, J.C.2
-
30
-
-
85040094617
-
Testing equality of variances of correlated variates with incomplete data on both responses
-
Bhoj, D.S. (1979) Testing equality of variances of correlated variates with incomplete data on both responses. Biometrika, 66, 681-683.
-
(1979)
Biometrika
, vol.66
, pp. 681-683
-
-
Bhoj, D.S.1
-
32
-
-
0035100888
-
Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
-
Biomarker Definition Working Group (2001) Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics, 69, 89-95.
-
(2001)
Clinical Pharmacology and Therapeutics
, vol.69
, pp. 89-95
-
-
-
33
-
-
0020308864
-
Proving the null hypothesis in clinical trials
-
Blackwelder, W.C. (1982) Proving the null hypothesis in clinical trials. Controlled Clinical Trials, 3, 345-353.
-
(1982)
Controlled Clinical Trials
, vol.3
, pp. 345-353
-
-
Blackwelder, W.C.1
-
34
-
-
0012340301
-
Conference Report. In:Bio-International: Bioavailability, Bioequivalence, and Pharmacokinetics
-
Blume, H.H., Midha, K.K., eds. (1993) Conference Report. In:Bio-International: Bioavailability, Bioequivalence, and Pharmacokinetics. Medpharm Stuttgart, 13-23.
-
(1993)
Medpharm Stuttgart
, pp. 13-23
-
-
Blume, H.H.1
Midha, K.K.2
-
35
-
-
0029567034
-
An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs
-
Boddy, A.W., Snikeris, F.C., Kringle, R.O., Wi, G.C.-G., Oppermann, J.A., Midha, K.K. (1995) An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs. Pharmaceutical Research, 12, 1865-1868.
-
(1995)
Pharmaceutical Research
, vol.12
, pp. 1865-1868
-
-
Boddy, A.W.1
Snikeris, F.C.2
Kringle, R.O.3
Wi, G.C.-G.4
Oppermann, J.A.5
Midha, K.K.6
-
36
-
-
0028223647
-
Bioequivalence: Performance of several measures of extent of absorption
-
Bois, F.Y., Tozer, T.N., Hauck, W.W., Chen, M.L., Patnaik, R., Williams, R. (1994) Bioequivalence: Performance of several measures of extent of absorption. Pharmaceutical Research, 11, 715-722.
-
(1994)
Pharmaceutical Research
, vol.11
, pp. 715-722
-
-
Bois, F.Y.1
Tozer, T.N.2
Hauck, W.W.3
Chen, M.L.4
Patnaik, R.5
Williams, R.6
-
37
-
-
83455207690
-
-
AAPS Press, Arlington, VA
-
Bonate, P., Howard, D., eds. (2004) Pharmacokinetics in Drug Development: Clinical Study Design and Analysis. AAPS Press, Arlington, VA.
-
(2004)
Pharmacokinetics in Drug Development: Clinical Study Design and Analysis
-
-
Bonate, P.1
Howard, D.2
-
38
-
-
0000133998
-
An analysis of transformations
-
Box, G.E., Cox, D.R. (1964) An analysis of transformations. Journal of the Royal Statistical Society, Series B, 26, 211-243.
-
(1964)
Journal of the Royal Statistical Society, Series B
, vol.26
, pp. 211-243
-
-
Box, G.E.1
Cox, D.R.2
-
39
-
-
84916821675
-
Use and abuse of regression
-
Box, G.E. (1966) Use and abuse of regression. Technometrics, 8, 625-629.
-
(1966)
Technometrics
, vol.8
, pp. 625-629
-
-
Box, G.E.1
-
40
-
-
0003100554
-
Robustness in the strategy of scientific model building
-
Launer, R.L., Wilkinson, G.N., eds, Academic Press: New York
-
Box, G.E. (1979) Robustness in the strategy of scientific model building. In Robustness in Statistics, Launer, R.L., Wilkinson, G.N., eds., 201-236. Academic Press: New York.
-
(1979)
Robustness in Statistics
, pp. 201-236
-
-
Box, G.E.1
-
41
-
-
0006982319
-
-
Elsevier, NY
-
Boxtel, C., Holford, N., Danhof, M., eds. (1992) The In Vivo Study of Drug Action. Elsevier, NY.
-
(1992)
The In Vivo Study of Drug Action
-
-
Boxtel, C.1
Holford, N.2
Danhof, M.3
-
42
-
-
84972544300
-
Biostatistics and Bayes
-
with discussion
-
Breslow, N. with discussion (1990) Biostatistics and Bayes. Statistical Science, 5, 269-298.
-
(1990)
Statistical Science
, vol.5
, pp. 269-298
-
-
Breslow, N.1
-
43
-
-
0026362989
-
Testing equality of treatment variances in a 2×2 cross-over study
-
Bristol, D.R. (1991a) Testing equality of treatment variances in a 2×2 cross-over study. Journal of Biopharmaceutical Statistics, 1, 185-192.
-
(1991)
Journal of Biopharmaceutical Statistics
, vol.1
, pp. 185-192
-
-
Bristol, D.R.1
-
44
-
-
0026363009
-
A confidence interval for the ratio of treatment variances in a 2 × 2 cross-over study
-
Bristol, D.R. (1991b) A confidence interval for the ratio of treatment variances in a 2 × 2 cross-over study. Journal of Biopharmaceutical Statistics, 1, 237-245.
-
(1991)
Journal of Biopharmaceutical Statistics
, vol.1
, pp. 237-245
-
-
Bristol, D.R.1
-
45
-
-
0018987266
-
The cross-over experiment for clinical trials
-
Brown, B.W. (1980) The cross-over experiment for clinical trials. Biometrics, 36, 69-79.
-
(1980)
Biometrics
, vol.36
, pp. 69-79
-
-
Brown, B.W.1
-
46
-
-
0030935677
-
Tolerance intervals for assessing individual bioequivalence
-
Brown, E.B., Iyer, H.K., Wang, C.M. (1997) Tolerance intervals for assessing individual bioequivalence. Statistics in Medicine, 16, 803-820.
-
(1997)
Statistics in Medicine
, vol.16
, pp. 803-820
-
-
Brown, E.B.1
Iyer, H.K.2
Wang, C.M.3
-
47
-
-
0028129339
-
The application of REML in clinical trials
-
Brown, H.K., Kempton, R.A. (1994) The application of REML in clinical trials. Statistics in Medicine, 13, 1601-1617.
-
(1994)
Statistics in Medicine
, vol.13
, pp. 1601-1617
-
-
Brown, H.K.1
Kempton, R.A.2
-
48
-
-
0039269080
-
An unbiased test for the bioequivalence problem
-
Brown, L.D., Hwang, J.T.G., Munk, A. (1997) An unbiased test for the bioequivalence problem. Annals of Statistics, 25, 2345-2367.
-
(1997)
Annals of Statistics
, vol.25
, pp. 2345-2367
-
-
Brown, L.D.1
Hwang, J.T.G.2
Munk, A.3
-
49
-
-
21844488686
-
Optimal confidence sets, bioequivalence, and the limacon of Pascal
-
Brown, L.B., Casella, G., Hwang, G. (1995) Optimal confidence sets, bioequivalence, and the limacon of Pascal. Journal of the American Statistical Association, 90, 880-889.
-
(1995)
Journal of the American Statistical Association
, vol.90
, pp. 880-889
-
-
Brown, L.B.1
Casella, G.2
Hwang, G.3
-
51
-
-
0029760455
-
Bioequivalence of a highly variable drug: An experience with Nadolol
-
Buice, R.G., Subramanian, V.S., Duchin, K.L., Uko-Nne, S. (1996) Bioequivalence of a highly variable drug: An experience with Nadolol. Pharmaceutical Research, 13, 1109-1115.
-
(1996)
Pharmaceutical Research
, vol.13
, pp. 1109-1115
-
-
Buice, R.G.1
Subramanian, V.S.2
Duchin, K.L.3
Uko-Nne, S.4
-
53
-
-
0000235075
-
Exact confidence intervals for linear combinations of variance components in nested classifications
-
Burdick, R.K., Sielken, R.L. (1978) Exact confidence intervals for linear combinations of variance components in nested classifications. Journal of the American Statistical Association, 73, 632-635.
-
(1978)
Journal of the American Statistical Association
, vol.73
, pp. 632-635
-
-
Burdick, R.K.1
Sielken, R.L.2
-
54
-
-
85052771985
-
The man who remade the universe
-
Burnham, R. (2005) The man who remade the universe. Astronomy, 33, 39-41.
-
(2005)
Astronomy
, vol.33
, pp. 39-41
-
-
Burnham, R.1
-
55
-
-
33745203168
-
-
Springer, NY
-
Burzykowski, T., Molenberghs, G., Buyse, M., eds. (2005) The Evaluation of Surrogate Endpoints Springer, NY.
-
(2005)
The Evaluation of Surrogate Endpoints
-
-
Burzykowski, T.1
Molenberghs, G.2
Buyse, M.3
-
56
-
-
0029980728
-
Bioequivalence and generic prescribing: A pharmacy view
-
Calvert, R.T. (1996) Bioequivalence and generic prescribing: a pharmacy view. Journal of Pharmacy and Pharmacology, 48, 9-10.
-
(1996)
Journal of Pharmacy and Pharmacology
, vol.48
, pp. 9-10
-
-
Calvert, R.T.1
-
59
-
-
0032766081
-
An individual bioequivalence approach to compare the intra-subject variability of two Ciclosporin formulations, SangCya and Neoral
-
Canafax, D.M., Irish, W.D., Moran, H.B., Squiers, E., Levy, R., Pouletty, P., First, M.R., Christians, U. (1999) An individual bioequivalence approach to compare the intra-subject variability of two Ciclosporin formulations, SangCya and Neoral. Pharmacology, 59, 78-88.
-
(1999)
Pharmacology
, vol.59
, pp. 78-88
-
-
Canafax, D.M.1
Irish, W.D.2
Moran, H.B.3
Squiers, E.4
Levy, R.5
Pouletty, P.6
First, M.R.7
Christians, U.8
-
60
-
-
0027165833
-
Differences in serum concentrations of and responses to generic verapamil in the elderly
-
Carter, B.L., Noyes, M.A., Demmler, R.W. (1993) Differences in serum concentrations of and responses to generic verapamil in the elderly. Pharmacotherapy, 13, 359-368.
-
(1993)
Pharmacotherapy
, vol.13
, pp. 359-368
-
-
Carter, B.L.1
Noyes, M.A.2
Demmler, R.W.3
-
61
-
-
0025998020
-
International harmonisation and consensus DIA meeting on bioavailability and bioequivalence requirements and standards
-
Cartwright, A.C. (1991) International harmonisation and consensus DIA meeting on bioavailability and bioequivalence requirements and standards. Drug Information Journal, 25, 471-482.
-
(1991)
Drug Information Journal
, vol.25
, pp. 471-482
-
-
Cartwright, A.C.1
-
63
-
-
0033105448
-
Bioequivalence of Levothyroxine tablets administered to a target population in steady state
-
Cerutti, R., Rivolta, G., Cavalieri, L., Di Giulio, C., Grossi, E., Vago, T., Baldi, G., Righini, V., Marzo, A. (1999) Bioequivalence of Levothyroxine tablets administered to a target population in steady state. Pharmacological Research, 39, 193-201.
-
(1999)
Pharmacological Research
, vol.39
, pp. 193-201
-
-
Cerutti, R.1
Rivolta, G.2
Cavalieri, L.3
Di Giulio, C.4
Grossi, E.5
Vago, T.6
Baldi, G.7
Righini, V.8
Marzo, A.9
-
64
-
-
0040778459
-
Bayesian analysis of disturbances variance in the linear regression model under assymetric loss assumptions
-
Chaturvedi, A., Bhatti, M.I., Kumar, K. (2000) Bayesian analysis of disturbances variance in the linear regression model under assymetric loss assumptions. Applied Mathematics and Computation, 114, 149-153.
-
(2000)
Applied Mathematics and Computation
, vol.114
, pp. 149-153
-
-
Chaturvedi, A.1
Bhatti, M.I.2
Kumar, K.3
-
65
-
-
0030503894
-
A confidence region approach for assessing equivalence in variability of bioavailability
-
Chen, K-W., Li, G., Sun, Y. (1996) A confidence region approach for assessing equivalence in variability of bioavailability. Biometrical Journal, 4, 475-487.
-
(1996)
Biometrical Journal
, vol.4
, pp. 475-487
-
-
Chen, K.-W.1
Li, G.2
Sun, Y.3
-
66
-
-
0030949859
-
Individual bioequivalence - a regulatory update
-
Chen, M.-L. (1997) Individual bioequivalence - a regulatory update. Journal of Biopharmaceutical Statistics, 7, 5-11.
-
(1997)
Journal of Biopharmaceutical Statistics
, vol.7
, pp. 5-11
-
-
Chen, M.-L.1
-
67
-
-
0034735563
-
An individual bioequivalence criterion:Regulatory considerations
-
Chen, M.-L., Patnaik, R., Hauck, W.H., Schuirmann, D.J., Hyslop, T., Williams, R. (2000a) An individual bioequivalence criterion:regulatory considerations. Statistics in Medicine, 19, 2821-2842.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2821-2842
-
-
Chen, M.-L.1
Patnaik, R.2
Hauck, W.H.3
Schuirmann, D.J.4
Hyslop, T.5
Williams, R.6
-
68
-
-
0033725193
-
Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics
-
Chen, M.-L., Lee, S-C., Ng, M-J., Schuirmann, D., Lesko, L.J., Williams, R.L. (2000b) Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics. Clinical Pharmacology and Therapeutics, 68, 510-521.
-
(2000)
Clinical Pharmacology and Therapeutics
, vol.68
, pp. 510-521
-
-
Chen, M.-L.1
Lee, S.-C.2
Ng, M.-J.3
Schuirmann, D.4
Lesko, L.J.5
Williams, R.L.6
-
69
-
-
0028361587
-
M-estimation in cross-over trials
-
Chi, E.M. (1994) M-estimation in cross-over trials. Biometrics, 50, 486-493.
-
(1994)
Biometrics
, vol.50
, pp. 486-493
-
-
Chi, E.M.1
-
71
-
-
0029965765
-
The assessment of individual and population bioequivalence
-
Chinchilli, V.M. (1996) The assessment of individual and population bioequivalence. Journal of Biopharmaceutical Statistics, 6, 1-14.
-
(1996)
Journal of Biopharmaceutical Statistics
, vol.6
, pp. 1-14
-
-
Chinchilli, V.M.1
-
73
-
-
0029744834
-
Design and analysis of intra-subject variability in cross-over experiments
-
Chinchilli, V.M., Esinhart, J.D. (1996) Design and analysis of intra-subject variability in cross-over experiments. Statistics in Medicine, 15, 1619-1634.
-
(1996)
Statistics in Medicine
, vol.15
, pp. 1619-1634
-
-
Chinchilli, V.M.1
Esinhart, J.D.2
-
75
-
-
38249031695
-
A new procedure for the estimation of variance components
-
Chow, S.C., Shao, J. (1988) A new procedure for the estimation of variance components. Statistics and Probability Letters, 6, 349-355.
-
(1988)
Statistics and Probability Letters
, vol.6
, pp. 349-355
-
-
Chow, S.C.1
Shao, J.2
-
76
-
-
0037088339
-
Individual bioequivalence testing under 2 × 3 designs
-
Chow, S.C., Shao, J., Wang, H. (2002a) Individual bioequivalence testing under 2 × 3 designs. Statistics in Medicine, 21, 629-48.
-
(2002)
Statistics in Medicine
, vol.21
, pp. 629-648
-
-
Chow, S.C.1
Shao, J.2
Wang, H.3
-
77
-
-
0036428658
-
Assessing sensitivity and similarity in bridging studies
-
Chow, S.C., Shao, J., Hu, O. (2002b) Assessing sensitivity and similarity in bridging studies. Journal of Biopharmaceutical Statistics, 12, 385-400.
-
(2002)
Journal of Biopharmaceutical Statistics
, vol.12
, pp. 385-400
-
-
Chow, S.C.1
Shao, J.2
Hu, O.3
-
78
-
-
0022449385
-
Critical therapeutic categories:A contraindication to generic substitution?
-
Colaizzi, J.L., Lowenthal, D.T. (1986) Critical therapeutic categories:A contraindication to generic substitution? Clinical Therapeutics, 8, 370-379.
-
(1986)
Clinical Therapeutics
, vol.8
, pp. 370-379
-
-
Colaizzi, J.L.1
Lowenthal, D.T.2
-
79
-
-
0033663490
-
Bioavailability and bioequivalence:Average, population, and/or individual
-
Colburn, W.A., Keefe, D.L. (2000) Bioavailability and bioequivalence:Average, population, and/or individual. Journal of Clinical Pharmacology, 40, 559-600.
-
(2000)
Journal of Clinical Pharmacology
, vol.40
, pp. 559-600
-
-
Colburn, W.A.1
Keefe, D.L.2
-
82
-
-
0040519899
-
Nonparametric tests of dispersion for the two period cross-over design
-
Cornell, R.G. (1991) Nonparametric tests of dispersion for the two period cross-over design. Commumications in Statistical Theory and Methodology, 20, 1099-1106.
-
(1991)
Commumications in Statistical Theory and Methodology
, vol.20
, pp. 1099-1106
-
-
Cornell, R.G.1
-
83
-
-
0014183790
-
Fieller’s theorem and a generalization
-
Cox, D.R. (1967) Fieller’s theorem and a generalization. Biometrika, 54, 567-572.
-
(1967)
Biometrika
, vol.54
, pp. 567-572
-
-
Cox, D.R.1
-
84
-
-
0003740564
-
-
Chapman and Hall, London
-
Crowder, M.J., Kimber, A.C., Smith, R.L., Sweeting, T.J. (1991) Statistical Analysis of Reliability Data., Chapman and Hall, London.
-
(1991)
Statistical Analysis of Reliability Data.
-
-
Crowder, M.J.1
Kimber, A.C.2
Smith, R.L.3
Sweeting, T.J.4
-
87
-
-
0034939341
-
Carry-over effects in bioequivalence studies
-
D’Angelo, G., Potvin, D., Turgeon, J. (2001) Carry-over effects in bioequivalence studies. Journal of Biopharmaceutical Statistics, 11, 27-36.
-
(2001)
Journal of Biopharmaceutical Statistics
, vol.11
, pp. 27-36
-
-
D’Angelo, G.1
Potvin, D.2
Turgeon, J.3
-
89
-
-
0025958371
-
Sample size determination for bioequivalence assessment by means of confidence intervals
-
Diletti, E., Hauschke, D., Steinijans, V.W. (1991) Sample size determination for bioequivalence assessment by means of confidence intervals. International Journal of Clinical Pharmacology, Therapeutics, and Toxicology, 29, 1-8.
-
(1991)
International Journal of Clinical Pharmacology, Therapeutics, and Toxicology
, vol.29
, pp. 1-8
-
-
Diletti, E.1
Hauschke, D.2
Steinijans, V.W.3
-
90
-
-
85052763467
-
New drug development in the USA from 1963 to 1999; Risks in new drug development - Approval success rates for investigational drugs
-
DiMasi, J. (2001) New drug development in the USA from 1963 to 1999; Risks in new drug development - Approval success rates for investigational drugs. Clinical Pharmacology and Therapeutics, 69, 286-307.
-
(2001)
Clinical Pharmacology and Therapeutics
, vol.69
, pp. 286-307
-
-
DiMasi, J.1
-
91
-
-
10944252443
-
Repeated-measures models in the analysis of QT-interval data
-
Dmitrienko, A., Smith, B. (2003) Repeated-measures models in the analysis of QT-interval data. Pharmaceutical Statistics, 2, 175-190.
-
(2003)
Pharmaceutical Statistics
, vol.2
, pp. 175-190
-
-
Dmitrienko, A.1
Smith, B.2
-
93
-
-
85052769004
-
The Total Least Squares Method in Individual Bioequivalence Evaluation
-
Dragalin, V., Fedorov, V. (1999b) The Total Least Squares Method in Individual Bioequivalence Evaluation. SB BDS Technical Report 1999-04.
-
(1999)
SB BDS Technical Report 1999-04
-
-
Dragalin, V.1
Fedorov, V.2
-
95
-
-
0017643592
-
Significance testing to establish equivalence between treatments, with special reference to data in the form of 2 × 2 tables
-
Dunnett, C.W., Gent, M. (1977) Significance testing to establish equivalence between treatments, with special reference to data in the form of 2 × 2 tables. Biometrics, 33, 593-602.
-
(1977)
Biometrics
, vol.33
, pp. 593-602
-
-
Dunnett, C.W.1
Gent, M.2
-
97
-
-
84980167912
-
A test for the equality of variances in the paired case with incomplete data
-
Ekbohm, E. (1981) A test for the equality of variances in the paired case with incomplete data. Biometrical Journal, 3, 261-265.
-
(1981)
Biometrical Journal
, vol.3
, pp. 261-265
-
-
Ekbohm, E.1
-
98
-
-
0024947084
-
The subject-by-formulation interaction as a criterion of interchangeability of drugs
-
Ekbohm, G., Melander, H. (1989) The subject-by-formulation interaction as a criterion of interchangeability of drugs. Biometrics, 45, 1249-1254.
-
(1989)
Biometrics
, vol.45
, pp. 1249-1254
-
-
Ekbohm, G.1
Melander, H.2
-
99
-
-
0031913404
-
Evaluation of bioequivalence of highly variable drug using clinical trial simulations. II: Comparison of Single and Multiple-Dose Trials using AUC and Cmax
-
El-Tahtawy, A.A., Tozer, T.N., Harrison, F., Lesko, L., Williams, R. (1998) Evaluation of bioequivalence of highly variable drug using clinical trial simulations. II: Comparison of Single and Multiple-Dose Trials using AUC and Cmax. Pharmaceutical Research, 15, 98-104.
-
(1998)
Pharmaceutical Research
, vol.15
, pp. 98-104
-
-
El-Tahtawy, A.A.1
Tozer, T.N.2
Harrison, F.3
Lesko, L.4
Williams, R.5
-
102
-
-
0025918379
-
Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence
-
Endrenyi, L., Fritsch, S., Yan, W. (1991) Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence. International Journal of Clinical Pharmacology, Therapy, and Toxicology, 29, 394-399.
-
(1991)
International Journal of Clinical Pharmacology, Therapy, and Toxicology
, vol.29
, pp. 394-399
-
-
Endrenyi, L.1
Fritsch, S.2
Yan, W.3
-
103
-
-
0027419507
-
Individual variation and the acceptance of average bioequivalence
-
Endrenyi, L., Schulz, M. (1993) Individual variation and the acceptance of average bioequivalence. Drug Information Journal, 27, 195-201.
-
(1993)
Drug Information Journal
, vol.27
, pp. 195-201
-
-
Endrenyi, L.1
Schulz, M.2
-
105
-
-
0031689198
-
Metrics comparing simulated early concentration profiles for the determination of bioequivalence
-
Endrenyi, L., Czimadia, F., Tothfalusi, L, Chen, M.L. (1998a) Metrics comparing simulated early concentration profiles for the determination of bioequivalence. Pharmaceutical Research, 15, 1292-1299.
-
(1998)
Pharmaceutical Research
, vol.15
, pp. 1292-1299
-
-
Endrenyi, L.1
Czimadia, F.2
Tothfalusi, L.3
Chen, M.L.4
-
106
-
-
0031721971
-
Individual bioequivalence: Attractive in principle, difficult in practice
-
Endrenyi, L., Amidon, G.L., Midha, K.K., Skelly, J.P. (1998b) Individual bioequivalence: Attractive in principle, difficult in practice. Pharmaceutical Research, 15, 1321-1325.
-
(1998)
Pharmaceutical Research
, vol.15
, pp. 1321-1325
-
-
Endrenyi, L.1
Amidon, G.L.2
Midha, K.K.3
Skelly, J.P.4
-
107
-
-
0031857671
-
Assymetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence
-
Endrenyi, L., Hao, Y. (1998c) Assymetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence. International Journal of Clinical Pharmacology, Therapy, and Toxicology, 36, 1-8.
-
(1998)
International Journal of Clinical Pharmacology, Therapy, and Toxicology
, vol.36
, pp. 1-8
-
-
Endrenyi, L.1
Hao, Y.2
-
109
-
-
0033013237
-
Subject-by-formulation interaction in determination of individual bioequivalence: Bias and prevalence
-
Endrenyi, L., Tothfalusi, L. (1999) Subject-by-formulation interaction in determination of individual bioequivalence: Bias and prevalence. Pharmaceutical Research, 16, 186-190.
-
(1999)
Pharmaceutical Research
, vol.16
, pp. 186-190
-
-
Endrenyi, L.1
Tothfalusi, L.2
-
110
-
-
0034735583
-
Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence
-
Endrenyi, L., Taback, N., Tothfalusi, L. (2000) Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence. Statistics in Medicine, 19, 2867-2878.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2867-2878
-
-
Endrenyi, L.1
Taback, N.2
Tothfalusi, L.3
-
111
-
-
0035075197
-
Comparison of the bioequivalence of generic versus branded Clozapine
-
Ereshefsky, L., Meyer, M. (2001) Comparison of the bioequivalence of generic versus branded Clozapine. Journal of Clinical Psychiatry, 62(Suppl 5), 3-27.
-
(2001)
Journal of Clinical Psychiatry
, vol.62
, pp. 3-27
-
-
Ereshefsky, L.1
Meyer, M.2
-
112
-
-
0028291201
-
Extensions to the use of tolerance intervals for the assessment of individual bioequivalence
-
Esinhart, J.D., Chinchilli, V.M. (1994a) Extensions to the use of tolerance intervals for the assessment of individual bioequivalence. Journal of Biopharmaceutical Statistics, 4, 39-52.
-
(1994)
Journal of Biopharmaceutical Statistics
, vol.4
, pp. 39-52
-
-
Esinhart, J.D.1
Chinchilli, V.M.2
-
134
-
-
85151689081
-
-
Data Analysis, and Regulatory Applications
-
FDA Guidance (2003a) Exposure-Response Relationships -Study Design, Data Analysis, and Regulatory Applications. http://www.fda.gov/cder/guidance
-
(2003)
Exposure-Response Relationships -Study Design
-
-
-
141
-
-
0006707782
-
Exact confidence sets for variance components in unbalanced mixed linear models
-
Fenech, A., Harville, D. (1991) Exact confidence sets for variance components in unbalanced mixed linear models. The Annals of Statistics, 19, 1771-1785.
-
(1991)
The Annals of Statistics
, vol.19
, pp. 1771-1785
-
-
Fenech, A.1
Harville, D.2
-
144
-
-
0344272718
-
On the distribution of a linear combination of independent chi squares
-
Fleiss, J.L. (1971) On the distribution of a linear combination of independent chi squares. Journal of the American Statistical Association, 66, 142-144.
-
(1971)
Journal of the American Statistical Association
, vol.66
, pp. 142-144
-
-
Fleiss, J.L.1
-
145
-
-
67649347419
-
Letter to the editor: On multiperiod cross-over studies
-
Fleiss, J.L. (1986) Letter to the editor: On multiperiod cross-over studies. Biometrics, 449-450.
-
(1986)
Biometrics
, pp. 449-450
-
-
Fleiss, J.L.1
-
146
-
-
0024347414
-
A critique of recent research on the two treatment cross-over design
-
Fleiss, J.L. (1989) A critique of recent research on the two treatment cross-over design. Controlled Clinical Trials, 10, 237-243.
-
(1989)
Controlled Clinical Trials
, vol.10
, pp. 237-243
-
-
Fleiss, J.L.1
-
147
-
-
0030268577
-
Surrogate endpoints in clinical trials: Are we being misled?
-
Fleming, T., DeMets, D. (1996) Surrogate endpoints in clinical trials: Are we being misled?. Annals of Internal Medicine, 125, 605-613.
-
(1996)
Annals of Internal Medicine
, vol.125
, pp. 605-613
-
-
Fleming, T.1
DeMets, D.2
-
148
-
-
0019513571
-
An aid to decision making in bioequivalence assessment
-
Fluehler, H., Hirtz, J., Moser, H.A. (1981) An aid to decision making in bioequivalence assessment. Journal of Pharmacokinetics and Biopharmaceutics, 9, 235-243.
-
(1981)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.9
, pp. 235-243
-
-
Fluehler, H.1
Hirtz, J.2
Moser, H.A.3
-
149
-
-
84980091069
-
Die systolendauer im elecktrokardiogramm bei normalen menschen und bei herzkranken
-
Fridericia, L. (1920) Die systolendauer im elecktrokardiogramm bei normalen menschen und bei herzkranken. Acta Medica Scandinavia, 53, 469-486.
-
(1920)
Acta Medica Scandinavia
, vol.53
, pp. 469-486
-
-
Fridericia, L.1
-
150
-
-
0024845507
-
The performance of the two-stage analysis of two treatment, two period cross-over trials
-
Freeman, P. (1989) The performance of the two-stage analysis of two treatment, two period cross-over trials. Statistics in Medicine, 8, 1421-1432.
-
(1989)
Statistics in Medicine
, vol.8
, pp. 1421-1432
-
-
Freeman, P.1
-
151
-
-
0004008434
-
-
Springer, New York
-
Friedman, L., Furberg, C., DeMets, D. (1998) Fundamentals of Clinical Trials, 3ed. Springer, New York.
-
(1998)
Fundamentals of Clinical Trials, 3ed.
-
-
Friedman, L.1
Furberg, C.2
DeMets, D.3
-
152
-
-
0032600426
-
Are the current bioequivalence standards sufficient for the acceptance of narrow therapeutic index drugs? Utilization of a computer simulated warfarin bioequivalence model
-
Friesen, M.H., Walker, S.E. (1999) Are the current bioequivalence standards sufficient for the acceptance of narrow therapeutic index drugs? Utilization of a computer simulated warfarin bioequivalence model. J Pharm Pharmaceut Sci, 2, 15-22.
-
(1999)
J Pharm Pharmaceut Sci
, vol.2
, pp. 15-22
-
-
Friesen, M.H.1
Walker, S.E.2
-
153
-
-
0026643737
-
Variance components in comparative bioavailability studies
-
Gaffney, M. (1992) Variance components in comparative bioavailability studies. Journal of Pharmaceutical Sciences, 81, 315-317.
-
(1992)
Journal of Pharmaceutical Sciences
, vol.81
, pp. 315-317
-
-
Gaffney, M.1
-
154
-
-
20444457583
-
Statistical methods for eliciting probability distributions
-
Garthwaite, P., Kadane, J., O’Hagan, A. (2005) Statistical methods for eliciting probability distributions. Journal of the American Statistical Association, 100, 680-700.
-
(2005)
Journal of the American Statistical Association
, vol.100
, pp. 680-700
-
-
Garthwaite, P.1
Kadane, J.2
O’Hagan, A.3
-
155
-
-
0033810574
-
Pharmacometrics: Modeling and simulation tools to improve decision making in clinical drug development
-
Geischke, R., Steimer, J.-L. (2000) Pharmacometrics: modeling and simulation tools to improve decision making in clinical drug development. European Journal of Drug Metabolism and Pharmacokinetics, 25, 49-58.
-
(2000)
European Journal of Drug Metabolism and Pharmacokinetics
, vol.25
, pp. 49-58
-
-
Geischke, R.1
Steimer, J.-L.2
-
156
-
-
84865262077
-
Illustration of Bayesian inference in normal data models using Gibbs sampling
-
Gelfland, A.E., Hills, S.E., Racine-Poon, A., Smith, A.F-M. (1990a) Illustration of Bayesian inference in normal data models using Gibbs sampling. Journal of the American Statistical Association, 85, 972-985.
-
(1990)
Journal of the American Statistical Association
, vol.85
, pp. 972-985
-
-
Gelfland, A.E.1
Hills, S.E.2
Racine-Poon, A.3
Smith, A.F.-M.4
-
158
-
-
85052774178
-
Comprehensive criteria for population and individual bioequivalence
-
Ghosh, K., Hesney, M., Sarkar, S., Thiyagarajan, B. (1996) Comprehensive criteria for population and individual bioequivalence. Proceedings of the American Statistical Association, Biopharmaceutics Chapter, 77-81.
-
(1996)
Proceedings of the American Statistical Association, Biopharmaceutics Chapter
, pp. 77-81
-
-
Ghosh, K.1
Hesney, M.2
Sarkar, S.3
Thiyagarajan, B.4
-
159
-
-
0141958842
-
Bayesian approach to average bioequivalence using Bayes’ factor
-
Ghosh, P., Khattree, R. (2003) Bayesian approach to average bioequivalence using Bayes’ factor. Journal of Biopharmaceutical Statistics, 13, 719-734.
-
(2003)
Journal of Biopharmaceutical Statistics
, vol.13
, pp. 719-734
-
-
Ghosh, P.1
Khattree, R.2
-
160
-
-
0001877178
-
Two-stage analysis based on a mixed model: Large sample asymptotic theory and small-sample simulation results
-
Giesbrecht, F., Burns, J. (1985) Two-stage analysis based on a mixed model: Large sample asymptotic theory and small-sample simulation results. Biometrics, 41, 477-486.
-
(1985)
Biometrics
, vol.41
, pp. 477-486
-
-
Giesbrecht, F.1
Burns, J.2
-
161
-
-
0003860037
-
-
Chapman and Hall, NY
-
Gilks, W.R., Richardson, S., Spiegelhalter, D. (1996) Markov Chain Monte Carlo in Practice, Chapman and Hall, NY.
-
(1996)
Markov Chain Monte Carlo in Practice
-
-
Gilks, W.R.1
Richardson, S.2
Spiegelhalter, D.3
-
162
-
-
0035693563
-
Utilisation of pharmacokineticpharmacodynamic modelling and simulation in regulatory decision making
-
Gobburu, J., Marroum, P. (2001) Utilisation of pharmacokineticpharmacodynamic modelling and simulation in regulatory decision making. Clinical Pharmacokinetics, 40, 883-892.
-
(2001)
Clinical Pharmacokinetics
, vol.40
, pp. 883-892
-
-
Gobburu, J.1
Marroum, P.2
-
163
-
-
0030017152
-
Bioequivalence assessment: A pharmaceutical industry perspective
-
Godbillon, J., Cardot, J.B., LeCaillon, G., Sioufi, A. (1996) Bioequivalence assessment: a pharmaceutical industry perspective. European Journal of Drug Metabolism and Pharmacokinetics, 21, 153-158.
-
(1996)
European Journal of Drug Metabolism and Pharmacokinetics
, vol.21
, pp. 153-158
-
-
Godbillon, J.1
Cardot, J.B.2
LeCaillon, G.3
Sioufi, A.4
-
164
-
-
0028304329
-
The use of predictive confidence intervals when planning experiments and the misuse of power when interpreting results
-
Goodman, S. (1994) The use of predictive confidence intervals when planning experiments and the misuse of power when interpreting results. Annals of Internal Medicine, 121, 200-206.
-
(1994)
Annals of Internal Medicine
, vol.121
, pp. 200-206
-
-
Goodman, S.1
-
165
-
-
0028863992
-
Group sequential extensions of a standard bioequivalence testing procedure
-
Gould, A.L. (1995) Group sequential extensions of a standard bioequivalence testing procedure. Journal of Pharmacokinetics and Biopharmaceutics, 23, 57-86.
-
(1995)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.23
, pp. 57-86
-
-
Gould, A.L.1
-
166
-
-
0030909029
-
Discussion of individual bioequivalence by M.L. Chen
-
Gould, A.L. (1997) Discussion of individual bioequivalence by M.L. Chen. Journal of Biopharmaceutical Statistics, 7, 23-29.
-
(1997)
Journal of Biopharmaceutical Statistics
, vol.7
, pp. 23-29
-
-
Gould, A.L.1
-
167
-
-
0034735587
-
A practical approach for evaluating population and individual bioequivalence
-
Gould, A.L. (2000) A practical approach for evaluating population and individual bioequivalence. Statistics in Medicine, 19, 2721-2740.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2721-2740
-
-
Gould, A.L.1
-
168
-
-
0021714621
-
Implications of intraindividual variability in bioavailability studies of furosemide
-
Grahnan, A., Hammarlund, M., Lundqvist, T. (1984) Implications of intraindividual variability in bioavailability studies of furosemide. European Journal of Clinical Pharmacology, 27, 595-602.
-
(1984)
European Journal of Clinical Pharmacology
, vol.27
, pp. 595-602
-
-
Grahnan, A.1
Hammarlund, M.2
Lundqvist, T.3
-
170
-
-
85052781273
-
A Bayesian analysis of the two-period crossover design for clinical trials
-
Grieve, A.P. (1985) A Bayesian analysis of the two-period crossover design for clinical trials. Biometrics, 21, 467-480.
-
(1985)
Biometrics
, vol.21
, pp. 467-480
-
-
Grieve, A.P.1
-
171
-
-
85052765319
-
Cross-over vs. Parallel Designs
-
Berry, D., ed., Marcel Dekker, New York
-
Grieve, A.P. (1990) Cross-over vs. Parallel Designs. In Statistical Methodology in the Pharmaceutical Sciences, Berry, D., ed., 239-270, Marcel Dekker, New York.
-
(1990)
Statistical Methodology in the Pharmaceutical Sciences
, pp. 239-270
-
-
Grieve, A.P.1
-
172
-
-
70449541670
-
The two-period changeover design and its use in clinical trials
-
Grizzle, J.E. (1965) The two-period changeover design and its use in clinical trials. Biometrics, 21, 467-480.
-
(1965)
Biometrics
, vol.21
, pp. 467-480
-
-
Grizzle, J.E.1
-
173
-
-
21144462871
-
Exact inference about the within-subject variability in 2 × 2 cross-over studies
-
Guilbaud, O. (1993) Exact inference about the within-subject variability in 2 × 2 cross-over studies. Journal of the American Statistical Association, 88, 939-946.
-
(1993)
Journal of the American Statistical Association
, vol.88
, pp. 939-946
-
-
Guilbaud, O.1
-
174
-
-
0033067447
-
Exact comparisons of means and variances in 2×2 cross-over trials
-
Guilbaud, O. (1999) Exact comparisons of means and variances in 2×2 cross-over trials. Drug Information Journal, 33, 455-469.
-
(1999)
Drug Information Journal
, vol.33
, pp. 455-469
-
-
Guilbaud, O.1
-
177
-
-
0002002390
-
Clinical trial simulation
-
Hale, M., Gillespie, W.R., Gupta, S.K., Tuk, B., Holford, N. (1996) Clinical trial simulation. Applied Clinical Trials, 6, 35-40.
-
(1996)
Applied Clinical Trials
, vol.6
, pp. 35-40
-
-
Hale, M.1
Gillespie, W.R.2
Gupta, S.K.3
Tuk, B.4
Holford, N.5
-
178
-
-
0025454416
-
The Orange Book: The FDA’s advice on therapeutic equivalence
-
Hare, D., Foster, T. (1990) The Orange Book: the FDA’s advice on therapeutic equivalence. American Pharmacy, NS30, 35-37.
-
(1990)
American Pharmacy
, vol.NS30
, pp. 35-37
-
-
Hare, D.1
Foster, T.2
-
180
-
-
0017156033
-
Confidence intervals and sets for linear combinations of fixed and random effects
-
Harville, D.A. (1976) Confidence intervals and sets for linear combinations of fixed and random effects. Biometrics, 32, 403-407.
-
(1976)
Biometrics
, vol.32
, pp. 403-407
-
-
Harville, D.A.1
-
181
-
-
84890913931
-
Maximum likelihood approaches to variance component estimation and to related problems
-
Harville, D.A. (1977) Maximum likelihood approaches to variance component estimation and to related problems. Journal of the American Statistical Association, 72, 320-340.
-
(1977)
Journal of the American Statistical Association
, vol.72
, pp. 320-340
-
-
Harville, D.A.1
-
182
-
-
0001619920
-
BLUP (best linear unbiased prediction) and beyond
-
Harville, D.A. (1990) BLUP (best linear unbiased prediction) and beyond. AdStMetGen, 239-276.
-
(1990)
AdStMetGen
, pp. 239-276
-
-
Harville, D.A.1
-
183
-
-
0027093902
-
Classical and Bayesian prediction as applied to an unbalanced mixed linear model
-
Harville, D.A., Carriquiry, A.L. (1992) Classical and Bayesian prediction as applied to an unbalanced mixed linear model. Biometrics, 48, 987-1003.
-
(1992)
Biometrics
, vol.48
, pp. 987-1003
-
-
Harville, D.A.1
Carriquiry, A.L.2
-
185
-
-
0030499611
-
The posterior distribution of the fixed and random effects in a mixed-effects linear model
-
Harville, D.A., Zimmermann, A.G. (1996) The posterior distribution of the fixed and random effects in a mixed-effects linear model. Journal of Statistical Computing and Simulation, 54, 211-229.
-
(1996)
Journal of Statistical Computing and Simulation
, vol.54
, pp. 211-229
-
-
Harville, D.A.1
Zimmermann, A.G.2
-
186
-
-
0021271539
-
A new statistical procedure for testing equivalence in two-group comparative bioavailability trials
-
Hauck, W.W., Anderson S. (1984) A new statistical procedure for testing equivalence in two-group comparative bioavailability trials. Journal of Pharmacokinetics and Biopharmaceutics, 12, 83-91.
-
(1984)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.12
, pp. 83-91
-
-
Hauck, W.W.1
Anderson, S.2
-
187
-
-
0022710709
-
A proposal for interpreting and reporting negative studies
-
Hauck, W.W., Anderson S. (1986) A proposal for interpreting and reporting negative studies. Statistics in Medicine, 5, 203-209.
-
(1986)
Statistics in Medicine
, vol.5
, pp. 203-209
-
-
Hauck, W.W.1
Anderson, S.2
-
188
-
-
0026597801
-
Types of bioequivalence and related statistical considerations
-
Hauck, W.W., Anderson S. (1992) Types of bioequivalence and related statistical considerations. International Journal of Clinical Pharmacology, Therapy, and Toxicology, 30, 181-187.
-
(1992)
International Journal of Clinical Pharmacology, Therapy, and Toxicology
, vol.30
, pp. 181-187
-
-
Hauck, W.W.1
Anderson, S.2
-
189
-
-
0028676114
-
Measuring switchability and presciptability: When is average bioequivalence sufficient
-
Hauck, W.W., Anderson S. (1994) Measuring switchability and presciptability: when is average bioequivalence sufficient. Journal of Pharmacokinetics and Biopharmaceutics, 22, 551-564.
-
(1994)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.22
, pp. 551-564
-
-
Hauck, W.W.1
Anderson, S.2
-
190
-
-
0033004225
-
Some issues in the design and analysis of equivalence trials
-
Hauck, W.W., Anderson, S. (1999) Some issues in the design and analysis of equivalence trials. Drug Information Journal, 33, 109-118.
-
(1999)
Drug Information Journal
, vol.33
, pp. 109-118
-
-
Hauck, W.W.1
Anderson, S.2
-
191
-
-
0028845789
-
Statistical and regulatory considerations for multiple measures in bioequivalence testing
-
Hauck, W.W., Hyslop, T., Anderson, S., Bois, F.Y., Tozer, T.N. (1995) Statistical and regulatory considerations for multiple measures in bioequivalence testing. Clinical Research and Regulatory Affairs, 12, 249-265.
-
(1995)
Clinical Research and Regulatory Affairs
, vol.12
, pp. 249-265
-
-
Hauck, W.W.1
Hyslop, T.2
Anderson, S.3
Bois, F.Y.4
Tozer, T.N.5
-
192
-
-
0030464885
-
Mean differences versus variability reduction:Tradeoff in aggregate measures for individual bioequivalence
-
for the FDA Individual Bioequivalence Working Group
-
Hauck, W.W, Chen, ML., Hyslop, T., Patnaik, P., Shuirmann, D., Williams, R., for the FDA Individual Bioequivalence Working Group. (1996) Mean differences versus variability reduction:tradeoff in aggregate measures for individual bioequivalence. International Journal of Clinical Pharmacology, Therapy, and Toxicology, 34, 535-541.
-
(1996)
International Journal of Clinical Pharmacology, Therapy, and Toxicology
, vol.34
, pp. 535-541
-
-
Hauck, W.W.1
Chen, M.L.2
Hyslop, T.3
Patnaik, P.4
Shuirmann, D.5
Williams, R.6
-
193
-
-
0030953502
-
Choice of Student’s t or Wilcoxon based confidence intervals for assessment of bioequivalence
-
Hauck, W.W., Hauschke, D., Diletti, E., Bois, F.Y., Steinijans, V.W., Anderson, S. (1997a) Choice of Student’s t or Wilcoxon based confidence intervals for assessment of bioequivalence. Journal of Biopharmaceutical Statistics, 7, 179-189.
-
(1997)
Journal of Biopharmaceutical Statistics
, vol.7
, pp. 179-189
-
-
Hauck, W.W.1
Hauschke, D.2
Diletti, E.3
Bois, F.Y.4
Steinijans, V.W.5
Anderson, S.6
-
194
-
-
0031018147
-
A parametric approach to population bioequivalence
-
Hauck, W.W, Bois, F.Y., Hyslop, T., Gee, L., Anderson, S. (1997b) A parametric approach to population bioequivalence. Statistics in Medicine, 16, 441-454.
-
(1997)
Statistics in Medicine
, vol.16
, pp. 441-454
-
-
Hauck, W.W.1
Bois, F.Y.2
Hyslop, T.3
Gee, L.4
Anderson, S.5
-
195
-
-
0030992033
-
A group sequential approach to cross-over trials for average bioequivalence
-
Hauck, W.W., Preston, P.E., Bois, F.Y. (1997c) A group sequential approach to cross-over trials for average bioequivalence. Journal of Biopharmaceutical Statistics, 7, 87-96.
-
(1997)
Journal of Biopharmaceutical Statistics
, vol.7
, pp. 87-96
-
-
Hauck, W.W.1
Preston, P.E.2
Bois, F.Y.3
-
196
-
-
0034123537
-
Subject-by-formulation interaction in bioequivalence:Conceptual and statistical issues
-
the FDA Population/Individual Bioequivalence Working Group
-
Hauck, W.W., Hyslop, T., Chen, M.L., Patnaik, R., Williams, R.L., and the FDA Population/Individual Bioequivalence Working Group. (2000) Subject-by-formulation interaction in bioequivalence:Conceptual and statistical issues. Pharmaceutical Research, 17, 375-380.
-
(2000)
Pharmaceutical Research
, vol.17
, pp. 375-380
-
-
Hauck, W.W.1
Hyslop, T.2
Chen, M.L.3
Patnaik, R.4
Williams, R.L.5
-
197
-
-
0034906872
-
Limits of 80%-125% for AUC and 70%-143% for Cmax - What is the impact on bioequivalence studies?
-
Hauck, W.W., Parekh, A., Lesko, L., Chen, M-L., Williams, R. (2001) Limits of 80%-125% for AUC and 70%-143% for Cmax - What is the impact on bioequivalence studies? International Journal of Clinical Pharmacology and Therapeutics, 39, 350-355.
-
(2001)
International Journal of Clinical Pharmacology and Therapeutics
, vol.39
, pp. 350-355
-
-
Hauck, W.W.1
Parekh, A.2
Lesko, L.3
Chen, M.-L.4
Williams, R.5
-
198
-
-
0025332058
-
A distribution free procedure for the statistical analysis of bioequivalence studies
-
Hauschke, D., Steinijans, V.W., Diletti, E. (1990) A distribution free procedure for the statistical analysis of bioequivalence studies. International Journal of Clinical Pharmacology, Therapy, and Toxicology, 28, 72-78.
-
(1990)
International Journal of Clinical Pharmacology, Therapy, and Toxicology
, vol.28
, pp. 72-78
-
-
Hauschke, D.1
Steinijans, V.W.2
Diletti, E.3
-
199
-
-
0012962972
-
Safety assessment in toxicological studies: Proof of safety versus proof of hazard
-
Chow, S., and Liu, J., eds, Marcel Dekker, New York
-
Hauschke, D., Hothorn, L. (1998) Safety assessment in toxicological studies: Proof of safety versus proof of hazard. In Design and Analysis of Animal Studies in Pharmaceutical Development, Chow, S., and Liu, J., eds., 197-226, Marcel Dekker, New York.
-
(1998)
Design and Analysis of Animal Studies in Pharmaceutical Development
, pp. 197-226
-
-
Hauschke, D.1
Hothorn, L.2
-
200
-
-
0034735555
-
The US draft guidance regarding population and individual bioequivalence approaches:Comments by a research-based pharmaceutical company
-
Hauschke, D., Steinijans, V.W. (2000) The US draft guidance regarding population and individual bioequivalence approaches:Comments by a research-based pharmaceutical company. Statistics in Medicine, 19, 2769-2774.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2769-2774
-
-
Hauschke, D.1
Steinijans, V.W.2
-
201
-
-
85052775362
-
Letter to the Editor and Correspondence on ‘A Note on Sample Size Calculation in Bioequivalence Trials’ by Chow and Wang (2001;28:155-169)
-
Hauschke, D. (2002) Letter to the Editor and Correspondence on ‘A Note on Sample Size Calculation in Bioequivalence Trials’ by Chow and Wang (2001;28:155-169). Journal of Pharmacokinetics and Pharmacodynamics, 29, 89-102.
-
(2002)
Journal of Pharmacokinetics and Pharmacodynamics
, vol.29
, pp. 89-102
-
-
Hauschke, D.1
-
202
-
-
0019492559
-
Statistical simulation study of new proposed uniformity requirement for bioequivalency studies
-
Haynes, J.D. (1981) Statistical simulation study of new proposed uniformity requirement for bioequivalency studies. Journal of Pharmaceutical Sciences, 70, 673-675.
-
(1981)
Journal of Pharmaceutical Sciences
, vol.70
, pp. 673-675
-
-
Haynes, J.D.1
-
203
-
-
0030444901
-
Interpatient variability in bioavailability is related to the extent of absorption:Implications for bioavailability and bioequivalence studies
-
Hellriegel, E.T., Bjornsson, T.D., Hauck, W.W. (1996) Interpatient variability in bioavailability is related to the extent of absorption:implications for bioavailability and bioequivalence studies. Clinical Pharmacology and Therapeutics, 60, 601-607.
-
(1996)
Clinical Pharmacology and Therapeutics
, vol.60
, pp. 601-607
-
-
Hellriegel, E.T.1
Bjornsson, T.D.2
Hauck, W.W.3
-
204
-
-
0030017104
-
Bioequivalence assessment and the conduct of bioequivalence trials: A European point of view
-
Herchuelz, A. (1996) Bioequivalence assessment and the conduct of bioequivalence trials: a European point of view. European Journal of Drug Metabolism and Pharmacokinetics, 21, 149-152.
-
(1996)
European Journal of Drug Metabolism and Pharmacokinetics
, vol.21
, pp. 149-152
-
-
Herchuelz, A.1
-
206
-
-
0003710995
-
-
John Wiley and Sons, New York
-
Hinkelmann, K., Kempthorne, O. (1994) Design and Analysis of Experiments, Volume I: Introduction to Experimental Design, John Wiley and Sons, New York.
-
(1994)
Design and Analysis of Experiments, Volume I: Introduction to Experimental Design
-
-
Hinkelmann, K.1
Kempthorne, O.2
-
208
-
-
0035644173
-
The abuse of power: The pervasive fallacy of power calculations for data analysis
-
Hoenig, J., Heisey, D. (2001) The abuse of power: The pervasive fallacy of power calculations for data analysis. The American Statistician, 55, 19-24.
-
(2001)
The American Statistician
, vol.55
, pp. 19-24
-
-
Hoenig, J.1
Heisey, D.2
-
209
-
-
0001474373
-
Moment based criteria for determining bioequivalence
-
Holder, D., Hsuan, F. (1993a) Moment based criteria for determining bioequivalence. Biometrika, 80, 835-846.
-
(1993)
Biometrika
, vol.80
, pp. 835-846
-
-
Holder, D.1
Hsuan, F.2
-
210
-
-
0029163331
-
A moment based criteria for determining individual bioequivalence
-
Holder, D., Hsuan, F. (1993b) A moment based criteria for determining individual bioequivalence. Drug Information Journal, 29, 965-979.
-
(1993)
Drug Information Journal
, vol.29
, pp. 965-979
-
-
Holder, D.1
Hsuan, F.2
-
211
-
-
0003834625
-
Simulation in drug development:Good practices
-
Holford, N.H.G., Hale, M., Ko, H.C., Steimer, J.-L., Sheiner, L.B., Peck, C.C. (1999) Simulation in drug development:good practices. Center for Drug Development Science, www.dml.georgetown.edu/cdds
-
(1999)
Center for Drug Development Science
-
-
Holford, N.H.G.1
Hale, M.2
Ko, H.C.3
Steimer, J.-L.4
Sheiner, L.B.5
Peck, C.C.6
-
213
-
-
0026671408
-
Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin
-
Honig, P., Woosley, R., Zamani, K., Conner, D., Cantilena, L. (1992) Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin. Clinical Pharmacology and Therapeutics, 52, 231-238.
-
(1992)
Clinical Pharmacology and Therapeutics
, vol.52
, pp. 231-238
-
-
Honig, P.1
Woosley, R.2
Zamani, K.3
Conner, D.4
Cantilena, L.5
-
214
-
-
0000722255
-
Approximate confidence limits on the mean of X+Y where X and Y are two tabled independent random variables
-
Howe, W.G. (1974) Approximate confidence limits on the mean of X+Y where X and Y are two tabled independent random variables. Journal of the American Statistical Association, 69, 789-794.
-
(1974)
Journal of the American Statistical Association
, vol.69
, pp. 789-794
-
-
Howe, W.G.1
-
215
-
-
0000224613
-
Confidence limits associated with tests for bioequivalence
-
Hsu, J.C., Hwang, J.-T.G., Liu, H-K., Ruberg, S.J. (1994) Confidence limits associated with tests for bioequivalence. Biometrika, 81, 103-114.
-
(1994)
Biometrika
, vol.81
, pp. 103-114
-
-
Hsu, J.C.1
Hwang, J.-T.G.2
Liu, H.-K.3
Ruberg, S.J.4
-
216
-
-
85056007658
-
A method for assigning confidence limits to linear combinations of variances
-
Huitson, A. (1955) A method for assigning confidence limits to linear combinations of variances. Biometrika, 42, 471-479.
-
(1955)
Biometrika
, vol.42
, pp. 471-479
-
-
Huitson, A.1
-
218
-
-
0040562162
-
Establishing therapeutic equivalence with clinical endpoints
-
Huque, M.F., Dubey, S., Fredd, S. (1989) Establishing therapeutic equivalence with clinical endpoints. Proceedings of the American Statistical Association, Biopharmaceutics Chapter, 46-52.
-
(1989)
Proceedings of the American Statistical Association, Biopharmaceutics Chapter
, pp. 46-52
-
-
Huque, M.F.1
Dubey, S.2
Fredd, S.3
-
219
-
-
84950658629
-
Conditions under which mean square ratios in repeated measures designs have exact Fdistributions
-
Huynh, H., Feldt, L.S. (1970) Conditions under which mean square ratios in repeated measures designs have exact Fdistributions. Journal of the American Statistical Association, 65, 1582-1589.
-
(1970)
Journal of the American Statistical Association
, vol.65
, pp. 1582-1589
-
-
Huynh, H.1
Feldt, L.S.2
-
220
-
-
25444457478
-
Numerical solutions for a sequential approach to bioequivalence
-
Hwang, J.S. (1996) Numerical solutions for a sequential approach to bioequivalence. Statistica Sinica, 6, 663-673.
-
(1996)
Statistica Sinica
, vol.6
, pp. 663-673
-
-
Hwang, J.S.1
-
221
-
-
0000590222
-
The validity of the test of individual equivalence ratios
-
Hwang, J.T.G., Wang, W. (1997) The validity of the test of individual equivalence ratios. Biometrika, 84, 893-900.
-
(1997)
Biometrika
, vol.84
, pp. 893-900
-
-
Hwang, J.T.G.1
Wang, W.2
-
222
-
-
0017979203
-
Bioequivalence and interchangeabiliy
-
Hwang, S., Huber, P.B., Hesney, M., Kwan, K.C. (1978) Bioequivalence and interchangeabiliy. Journal of Pharmaceutical Sciences, 67, IV.
-
(1978)
Journal of Pharmaceutical Sciences
, vol.67
-
-
Hwang, S.1
Huber, P.B.2
Hesney, M.3
Kwan, K.C.4
-
223
-
-
0034735561
-
A small sample confidence interval approach to assess individual bioequivalence
-
Hyslop, T., Hsuan, F., Holder, D.J. (2000) A small sample confidence interval approach to assess individual bioequivalence. Statistics in Medicine, 19, 2885-2897.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2885-2897
-
-
Hyslop, T.1
Hsuan, F.2
Holder, D.J.3
-
228
-
-
85151631286
-
International Conference on Harmonization
-
International Conference on Harmonization (1998) Statistical Principles for Clinical Trials. http://www.fda.gov/cder/guidance
-
(1998)
Statistical Principles for Clinical Trials
-
-
-
230
-
-
0034495152
-
The role of metabolites in bioequivalency assessment. III. Highly variable drugs with linear kinetics and firstpass effect
-
Jackson, A. (2000) The role of metabolites in bioequivalency assessment. III. Highly variable drugs with linear kinetics and firstpass effect. Pharmaceutical Research, 17, 1432-1436.
-
(2000)
Pharmaceutical Research
, vol.17
, pp. 1432-1436
-
-
Jackson, A.1
-
231
-
-
3242772217
-
Metabolites and bioequivalence - past and present
-
Jackson, A., Robbie, G., Marroum, P. (2004) Metabolites and bioequivalence - past and present. Clinical Pharmacokinetics, 43, 655-672.
-
(2004)
Clinical Pharmacokinetics
, vol.43
, pp. 655-672
-
-
Jackson, A.1
Robbie, G.2
Marroum, P.3
-
234
-
-
0022966316
-
Unbalanced repeatedmeasures models with structured covariance matrices
-
Jennrich, R.I., Schluchter, M.D. (1986) Unbalanced repeatedmeasures models with structured covariance matrices. Biometrics, 42, 805-820.
-
(1986)
Biometrics
, vol.42
, pp. 805-820
-
-
Jennrich, R.I.1
Schluchter, M.D.2
-
235
-
-
0003446320
-
-
John Wiley and Sons, New York
-
Johnson, N.L., Kotz, S., Balakrishnan, N. (1994) Continuous Univariate Distributions, Vols. 1 and 2. John Wiley and Sons, New York.
-
(1994)
Continuous Univariate Distributions, Vols. 1 and 2
-
-
Johnson, N.L.1
Kotz, S.2
Balakrishnan, N.3
-
236
-
-
4544272183
-
Potential clinical implications of substitution of generic formulations for cyclosporine microemulsion (Neoral) in transplant recipients
-
Johnston, A., Belitsky, P., Frei, U., Horvath, J., Hoyer, P., Helderman, J., Oellerich, M., Pollard, S., Riad, H., Rigotti, P., Keown, P., Nashan, B. (2004) Potential clinical implications of substitution of generic formulations for cyclosporine microemulsion (Neoral) in transplant recipients. European Journal of Clinical Pharmacology, 60, 389-395.
-
(2004)
European Journal of Clinical Pharmacology
, vol.60
, pp. 389-395
-
-
Johnston, A.1
Belitsky, P.2
Frei, U.3
Horvath, J.4
Hoyer, P.5
Helderman, J.6
Oellerich, M.7
Pollard, S.8
Riad, H.9
Rigotti, P.10
Keown, P.11
Nashan, B.12
-
238
-
-
0029987569
-
Trials to assess equivalence: The importance of rigourous methods
-
Jones, B., Jarvis, P., Lewis, J.A., Ebbutt, A.F. (1996) Trials to assess equivalence: The importance of rigourous methods. British Medical Journal, 313, 36-39.
-
(1996)
British Medical Journal
, vol.313
, pp. 36-39
-
-
Jones, B.1
Jarvis, P.2
Lewis, J.A.3
Ebbutt, A.F.4
-
239
-
-
67650396671
-
-
GenStat Release 7.1 Reference Manual, Part 3: Procedure Library PL15, VSN International, Oxford
-
Jones, B., Lane, P.W. (2004). Procedure XOEFFICIENCY (Calculates efficiency of effects in cross-over designs). GenStat Release 7.1 Reference Manual, Part 3: Procedure Library PL15, VSN International, Oxford.
-
(2004)
Procedure XOEFFICIENCY (Calculates efficiency of effects in cross-over designs)
-
-
Jones, B.1
Lane, P.W.2
-
242
-
-
10644225889
-
Sample sizes for estimation in clinical research
-
Julious, S., Patterson, S. (2004) Sample sizes for estimation in clinical research. Pharmaceutical Statistics, 3, 213-215.
-
(2004)
Pharmaceutical Statistics
, vol.3
, pp. 213-215
-
-
Julious, S.1
Patterson, S.2
-
243
-
-
85052776297
-
A Two-Stage Procedure for Testing Bioequivalence
-
Kanfer, F.-H.J., Geertsema, J.C., Steyn, H.S. (1988) A Two-Stage Procedure for Testing Bioequivalence. Proceedings of the American Statistical Association, 148-152.
-
(1988)
Proceedings of the American Statistical Association
, pp. 148-152
-
-
Kanfer, F.-H.J.1
Geertsema, J.C.2
Steyn, H.S.3
-
244
-
-
0033697706
-
Statistical approaches to accepting foreign clinical data
-
Kawai, N., Andoh, M., Uwoi, T., Goto, M. (2000) Statistical approaches to accepting foreign clinical data. Drug Information Journal, 34, 1265-1272.
-
(2000)
Drug Information Journal
, vol.34
, pp. 1265-1272
-
-
Kawai, N.1
Andoh, M.2
Uwoi, T.3
Goto, M.4
-
245
-
-
21244433490
-
Assessment of clinical relevance by considering point estimates and associated confidence intervals
-
Keiser, M., Hauschke, D. (2005) Assessment of clinical relevance by considering point estimates and associated confidence intervals. Pharmaceutical Statistics, 4, 101-107.
-
(2005)
Pharmaceutical Statistics
, vol.4
, pp. 101-107
-
-
Keiser, M.1
Hauschke, D.2
-
246
-
-
0030880605
-
Small sample inference for fixed effects from restricted maximum likelihood
-
Kenward, M., Roger, J. (1997) Small sample inference for fixed effects from restricted maximum likelihood. Biometrics, 33, 983-997.
-
(1997)
Biometrics
, vol.33
, pp. 983-997
-
-
Kenward, M.1
Roger, J.2
-
249
-
-
0031396991
-
A parametric confidence interval for a moment based scaled criterion for individual bioequivalence
-
Kimanani, E.K., Potvin, D. (1997) A parametric confidence interval for a moment based scaled criterion for individual bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics, 25, 595-614.
-
(1997)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.25
, pp. 595-614
-
-
Kimanani, E.K.1
Potvin, D.2
-
250
-
-
0034735562
-
Numerical methods for the evaluation of individual bioequivalence
-
Kimanani, E.K., Lavigne, J., Potvin, D. (2000a) Numerical methods for the evaluation of individual bioequivalence. Statistics in Medicine, 19, 2775-2795.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2775-2795
-
-
Kimanani, E.K.1
Lavigne, J.2
Potvin, D.3
-
251
-
-
0033668827
-
A contract research organization’s response to the new FDA guidances for bioequivalence/bioavailability studies for orally administered drug products
-
Kimanani, E., Stypinski, D., Curtis, G., Stiles, M., Heessels, P., Logan, S., Melson, K., St Germain, E., Boswell, G. (2000b) A contract research organization’s response to the new FDA guidances for bioequivalence/bioavailability studies for orally administered drug products. Journal of Clinical Pharmacology, 40, 1102-1108.
-
(2000)
Journal of Clinical Pharmacology
, vol.40
, pp. 1102-1108
-
-
Kimanani, E.1
Stypinski, D.2
Curtis, G.3
Stiles, M.4
Heessels, P.5
Logan, S.6
Melson, K.7
St Germain, E.8
Boswell, G.9
-
252
-
-
0001305791
-
Letter to the editor and response
-
Kirkwood, T-B.L., Westlake, T.J. (1981) Letter to the editor and response. Biometrics, 37, 589-593.
-
(1981)
Biometrics
, vol.37
, pp. 589-593
-
-
Kirkwood, T.-B.L.1
Westlake, T.J.2
-
253
-
-
0015356770
-
The use of non-parametric methods in the statistical analysis of the two-period changeover design
-
Koch, G. (1972) The use of non-parametric methods in the statistical analysis of the two-period changeover design. Biometrics, 28, 577-584.
-
(1972)
Biometrics
, vol.28
, pp. 577-584
-
-
Koch, G.1
-
254
-
-
15844389520
-
Performance of some multiple testing procedures to compare three doses of a test drug and placebo
-
Kong, L., Koch, G., Liu, T., Wang, H. (2004) Performance of some multiple testing procedures to compare three doses of a test drug and placebo. Pharmaceutical Statistics, 4, 25-35.
-
(2004)
Pharmaceutical Statistics
, vol.4
, pp. 25-35
-
-
Kong, L.1
Koch, G.2
Liu, T.3
Wang, H.4
-
256
-
-
0029096291
-
Glaxo’s expreience of different absorption rate metrics of immediate release and extended release dosage forms
-
Lacey, L.F., Keene, O.N., Bye, A. (1995) Glaxo’s expreience of different absorption rate metrics of immediate release and extended release dosage forms. Drug Information Journal, 29, 821-840.
-
(1995)
Drug Information Journal
, vol.29
, pp. 821-840
-
-
Lacey, L.F.1
Keene, O.N.2
Bye, A.3
-
257
-
-
0030949860
-
Common noncompartmental pharmacokinetic variables: Are they normally or log-normally distributed?
-
Lacey, L.F., Keene, O.N., Pritchard, J.F., Bye, A. (1997) Common noncompartmental pharmacokinetic variables: are they normally or log-normally distributed? Journal of Biopharmaceutical Statistics, 7, 171-178.
-
(1997)
Journal of Biopharmaceutical Statistics
, vol.7
, pp. 171-178
-
-
Lacey, L.F.1
Keene, O.N.2
Pritchard, J.F.3
Bye, A.4
-
258
-
-
0346258216
-
Proper metrics for clinical trials: Transformations and other procedures to remove non-normality effects
-
Lachenbruch, P. (2003) Proper metrics for clinical trials: transformations and other procedures to remove non-normality effects. Statistics in Medicine, 22, 3823-3842.
-
(2003)
Statistics in Medicine
, vol.22
, pp. 3823-3842
-
-
Lachenbruch, P.1
-
259
-
-
0020333131
-
Random effects models for longitudinal data
-
Laird, N.M., Ware, J.H. (1982) Random effects models for longitudinal data. Biometrics, 38, 963-974.
-
(1982)
Biometrics
, vol.38
, pp. 963-974
-
-
Laird, N.M.1
Ware, J.H.2
-
260
-
-
0036448950
-
Tests for intersubject and total variabilities under cross-over designs
-
Lee, Y., Shao, J., Chow, S-C., Wang, H. (2002) Tests for intersubject and total variabilities under cross-over designs. Journal of Biopharmaceutical Statistics, 12(4), 503-534.
-
(2002)
Journal of Biopharmaceutical Statistics
, vol.12
, Issue.4
, pp. 503-534
-
-
Lee, Y.1
Shao, J.2
Chow, S.-C.3
Wang, H.4
-
262
-
-
0034029795
-
Optimizing the Science of Drug Development: Opportunities for better candidate selection and accelerated evaluation in humans
-
Lesko, L., Rowland, M., Peck, C., Blaschke, T. (2000) Optimizing the Science of Drug Development: opportunities for better candidate selection and accelerated evaluation in humans. European Journal of Pharmaceutical Sciences, 10, iv-xiv.
-
(2000)
European Journal of Pharmaceutical Sciences
, vol.10
, pp. iv-xiv
-
-
Lesko, L.1
Rowland, M.2
Peck, C.3
Blaschke, T.4
-
263
-
-
0035037328
-
Use of biomarkers and surrogate markers in drug development
-
Lesko, L., Atkinson, A. (2001) Use of biomarkers and surrogate markers in drug development. Annu. Rev. Pharmacol. Toxicol., 41, 347-66.
-
(2001)
Annu. Rev. Pharmacol. Toxicol.
, vol.41
, pp. 347-366
-
-
Lesko, L.1
Atkinson, A.2
-
264
-
-
0029615392
-
The clay feet of bioequivalence testing
-
Levy, G. (1995) The clay feet of bioequivalence testing. Journal of Pharmacy and Pharmacology, 47, 975-977.
-
(1995)
Journal of Pharmacy and Pharmacology
, vol.47
, pp. 975-977
-
-
Levy, G.1
-
265
-
-
0003605027
-
-
SAS Institute, Cary, North Carolina
-
Littell, R.C., Milliken, G.A., Stroup, W.W., Wolfinger, R.D. (1996) SAS System for Mixed Models. SAS Institute, Cary, North Carolina.
-
(1996)
SAS System for Mixed Models
-
-
Littell, R.C.1
Milliken, G.A.2
Stroup, W.W.3
Wolfinger, R.D.4
-
266
-
-
0024521543
-
A concordance correlation coefficient to evaluate reproducibility
-
Lin, L. (1989) A concordance correlation coefficient to evaluate reproducibility. Biometrics, 45, 255-268.
-
(1989)
Biometrics
, vol.45
, pp. 255-268
-
-
Lin, L.1
-
267
-
-
0026708519
-
Assay validation using the concordance correlation coefficient
-
Lin, L. (1992) Assay validation using the concordance correlation coefficient. Biometrics, 48, 599-604.
-
(1992)
Biometrics
, vol.48
, pp. 599-604
-
-
Lin, L.1
-
268
-
-
0034731817
-
Total deviation index for measuring individual agreement with applications in laboratory performance and bioequivalence
-
Lin, L. (2000) Total deviation index for measuring individual agreement with applications in laboratory performance and bioequivalence. Statistics in Medicine, 19, 255-270.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 255-270
-
-
Lin, L.1
-
270
-
-
0343352821
-
On the evidence needed to reach agreed action between adversaries, with application to acceptance sampling
-
Lindley, D.V, Singpurwalla, N.D. (1991) On the evidence needed to reach agreed action between adversaries, with application to acceptance sampling. Journal of the American Statistical Association, 86, 933-937.
-
(1991)
Journal of the American Statistical Association
, vol.86
, pp. 933-937
-
-
Lindley, D.V.1
Singpurwalla, N.D.2
-
271
-
-
0346983718
-
The choice of sample size (with discussion)
-
Lindley, D.V. (1997) The choice of sample size (with discussion). The Statistician, 46, 129-166.
-
(1997)
The Statistician
, vol.46
, pp. 129-166
-
-
Lindley, D.V.1
-
272
-
-
0001157809
-
Decision analysis and bioequivalence trials
-
Lindley, D.V. (1998) Decision analysis and bioequivalence trials. Statistical Science, 13, 136-141.
-
(1998)
Statistical Science
, vol.13
, pp. 136-141
-
-
Lindley, D.V.1
-
275
-
-
0030869446
-
Treatment-patient interactions for diagnostics of cross-over trials
-
Lindsey, J.K., Jones, B. (1997) Treatment-patient interactions for diagnostics of cross-over trials. Statistics in Medicine, 16, 1955-1964.
-
(1997)
Statistics in Medicine
, vol.16
, pp. 1955-1964
-
-
Lindsey, J.K.1
Jones, B.2
-
276
-
-
0032839478
-
Modeling the covariance structure in pharmacokinetic cross-over trials
-
Lindsey, J.K., Wang, J., Byrom, W.D., Jones, B. (1999) Modeling the covariance structure in pharmacokinetic cross-over trials. Journal of Biopharmaceutical Statistics, 9, 439-450.
-
(1999)
Journal of Biopharmaceutical Statistics
, vol.9
, pp. 439-450
-
-
Lindsey, J.K.1
Wang, J.2
Byrom, W.D.3
Jones, B.4
-
277
-
-
84950419603
-
Newton-Raphson and EM algorithms for linear mixed-effects models and repeated-measures data
-
Lindstrom, M.J., Bates, D.M. (1988) Newton-Raphson and EM algorithms for linear mixed-effects models and repeated-measures data. Journal of the American Statisticial Association, 83, 1014-1022.
-
(1988)
Journal of the American Statisticial Association
, vol.83
, pp. 1014-1022
-
-
Lindstrom, M.J.1
Bates, D.M.2
-
279
-
-
0036428684
-
Bayesian approach to evaluation of bridging studies
-
Liu, J.-P., Hsiao, C-F., Hsueh, H. (2002b) Bayesian approach to evaluation of bridging studies. Journal of Biopharmaceutical Statistics, 12, 401-408.
-
(2002)
Journal of Biopharmaceutical Statistics
, vol.12
, pp. 401-408
-
-
Liu, J.-P.1
Hsiao, C.-F.2
Hsueh, H.3
-
280
-
-
2642561923
-
A Bayesian noninferiority approach to evaluation of bridging studies
-
Liu, J-P., Hsueh, H., Hsiao, C-F. (2004) A Bayesian noninferiority approach to evaluation of bridging studies. Journal of Biopharmaceutical Statistics, 14, 291-300.
-
(2004)
Journal of Biopharmaceutical Statistics
, vol.14
, pp. 291-300
-
-
Liu, J.-P.1
Hsueh, H.2
Hsiao, C.-F.3
-
281
-
-
0021702968
-
An exact confidence interval for untransformed data for the ratio of two formulation means
-
Locke, C.S. (1984) An exact confidence interval for untransformed data for the ratio of two formulation means. Journal of Pharmacokinetics and Biopharmaceutics, 12, 649-655.
-
(1984)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.12
, pp. 649-655
-
-
Locke, C.S.1
-
282
-
-
0033618144
-
Selection bias and treatment heterogeneity in clinical trials
-
Longford, N.T. (1999) Selection bias and treatment heterogeneity in clinical trials. Statistics in Medicine, 18, 1467-1474.
-
(1999)
Statistics in Medicine
, vol.18
, pp. 1467-1474
-
-
Longford, N.T.1
-
283
-
-
0034348930
-
An alternative definition of individual bioequivalence
-
Longford, N.T. (2000) An alternative definition of individual bioequivalence. Statistica Neerlandica, 14, 14-36.
-
(2000)
Statistica Neerlandica
, vol.14
, pp. 14-36
-
-
Longford, N.T.1
-
284
-
-
45549113468
-
Confidence intervals on a difference of expected mean squares
-
Lu, T.C., Graybill, F.A., Burdick, R.K. (1988) Confidence intervals on a difference of expected mean squares. Journal of Statistical Planning and Inference, 18, 35-43.
-
(1988)
Journal of Statistical Planning and Inference
, vol.18
, pp. 35-43
-
-
Lu, T.C.1
Graybill, F.A.2
Burdick, R.K.3
-
285
-
-
0016572161
-
Tables for an approximate test for outliers in linear models
-
Lund, R.E. (1975) Tables for an approximate test for outliers in linear models. Technometrics, 17, 473-476.
-
(1975)
Technometrics
, vol.17
, pp. 473-476
-
-
Lund, R.E.1
-
286
-
-
0033435139
-
A regulatory perspective on pharmacokinetic and pharmacodynamic modelling
-
Machado, S., Miller, R., Hu, C. (1999) A regulatory perspective on pharmacokinetic and pharmacodynamic modelling. Statistical Methods in Medical Research, 8, 217-245.
-
(1999)
Statistical Methods in Medical Research
, vol.8
, pp. 217-245
-
-
Machado, S.1
Miller, R.2
Hu, C.3
-
287
-
-
0001700822
-
A maximum likelihood estimation method for random coefficient regression models
-
Mallet, A. (1986) A maximum likelihood estimation method for random coefficient regression models. Biometrika, 73, 645-656.
-
(1986)
Biometrika
, vol.73
, pp. 645-656
-
-
Mallet, A.1
-
288
-
-
0035133672
-
The pharmacokinetics and metabolic disposition of Tacrolimus: A comparison across ethnic groups
-
Mancinelli, L., Frassetto, L., Floren, L., Dressler, D., Carrier, S., Bekersky, I., Benet, L., Christians, U. (2001) The pharmacokinetics and metabolic disposition of Tacrolimus: A comparison across ethnic groups. Clinical Pharmacology and Therapeutics, 69, 24-31.
-
(2001)
Clinical Pharmacology and Therapeutics
, vol.69
, pp. 24-31
-
-
Mancinelli, L.1
Frassetto, L.2
Floren, L.3
Dressler, D.4
Carrier, S.5
Bekersky, I.6
Benet, L.7
Christians, U.8
-
289
-
-
0019576616
-
Comparison of different methods for decison making in bioequivalence assessment
-
Mandallaz, D., Mau, J. (1981) Comparison of different methods for decison making in bioequivalence assessment. Biometrics, 37, 213-222.
-
(1981)
Biometrics
, vol.37
, pp. 213-222
-
-
Mandallaz, D.1
Mau, J.2
-
290
-
-
0017146303
-
On closed testing procedures with special reference to ordered analysis of variance
-
Marcus, R., Peritz, E., Gabriel, K.R. (1976) On closed testing procedures with special reference to ordered analysis of variance. Biometrika, 63, 655-60.
-
(1976)
Biometrika
, vol.63
, pp. 655-660
-
-
Marcus, R.1
Peritz, E.2
Gabriel, K.R.3
-
291
-
-
0030772854
-
Evaluation of direct curve comparison metrics applied to pharmacokinetic profiles and relative bioavailability and bioequivalence
-
Marston, S.A., Polli, J.E. (1997) Evaluation of direct curve comparison metrics applied to pharmacokinetic profiles and relative bioavailability and bioequivalence. Pharmaceutical Research, 14, 1363-1369.
-
(1997)
Pharmaceutical Research
, vol.14
, pp. 1363-1369
-
-
Marston, S.A.1
Polli, J.E.2
-
292
-
-
0033916669
-
Bioequivalence of inhaled Formoterol Fumurate assessed from pharmacodynamic, safety, and urinary pharmacokinetic data
-
Marzo, A., Monti, N.C., Tettamanti, R.A., Crivelli, F., Bo, L.D., Mazzucchelli, P., Meoli, A., Pezzuto, D., Corsico, A. (2000) Bioequivalence of inhaled Formoterol Fumurate assessed from pharmacodynamic, safety, and urinary pharmacokinetic data. Arzneim-Forsch./Drug Res., 50, 559-563.
-
(2000)
Arzneim-Forsch./Drug Res.
, vol.50
, pp. 559-563
-
-
Marzo, A.1
Monti, N.C.2
Tettamanti, R.A.3
Crivelli, F.4
Bo, L.D.5
Mazzucchelli, P.6
Meoli, A.7
Pezzuto, D.8
Corsico, A.9
-
293
-
-
0042504519
-
Modelling and optimality in the design of cross-over studies for medical applications
-
Matthews, J. (1994) Modelling and optimality in the design of cross-over studies for medical applications. Journal of Statistical Planning and Inference, 42, 89-108.
-
(1994)
Journal of Statistical Planning and Inference
, vol.42
, pp. 89-108
-
-
Matthews, J.1
-
294
-
-
0034735564
-
An alternative index for assessing profile similarity in bioequivalence trials
-
Mauger, D.T., Chinchilli, V.M. (2000) An alternative index for assessing profile similarity in bioequivalence trials. Statistics in Medicine, 19, 2855-2866.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2855-2866
-
-
Mauger, D.T.1
Chinchilli, V.M.2
-
296
-
-
0036144662
-
Pharmacokineticpharmacodynamic studies in drug product development
-
Meibohm, B., Derendorf, H. (2002) Pharmacokineticpharmacodynamic studies in drug product development. Journal of Pharmaceutical Sciences, 91, 18-31.
-
(2002)
Journal of Pharmaceutical Sciences
, vol.91
, pp. 18-31
-
-
Meibohm, B.1
Derendorf, H.2
-
297
-
-
0016206702
-
Bioavailability: A problem in equivalence
-
Metzler, C.M. (1974) Bioavailability: A problem in equivalence. Biometrics, 30, 309-317.
-
(1974)
Biometrics
, vol.30
, pp. 309-317
-
-
Metzler, C.M.1
-
299
-
-
0029101264
-
Current scientific issues regarding bioavailability/ bioequivalence studies: An academic view
-
Meyer, M.C. (1995) Current scientific issues regarding bioavailability/ bioequivalence studies: An academic view. Drug Information Journal, 29, 805-812.
-
(1995)
Drug Information Journal
, vol.29
, pp. 805-812
-
-
Meyer, M.C.1
-
300
-
-
0034120206
-
Bioequivalence of Methylphenidate immediate-release tablets using a replicated study design to characterize intra-subject variability
-
Meyer, M.C., Straughn, A.B., Jarvi, E.J., Patrick, K.S., Pelsor, F.R., Williams, R.L., Patnaik, R., Chen, M.L., Shah, V.P. (2000) Bioequivalence of Methylphenidate immediate-release tablets using a replicated study design to characterize intra-subject variability. Pharmaceutical Research, 17, 381-384.
-
(2000)
Pharmaceutical Research
, vol.17
, pp. 381-384
-
-
Meyer, M.C.1
Straughn, A.B.2
Jarvi, E.J.3
Patrick, K.S.4
Pelsor, F.R.5
Williams, R.L.6
Patnaik, R.7
Chen, M.L.8
Shah, V.P.9
-
301
-
-
0034955449
-
Variability in the bioavailability of Phenytoin capsules in males and females
-
Meyer, M.C., Straughn, A.B., Mhatre, R.M., Shah, V.P., Chen, M.-L., Williams, R.L., Lesko, L.J. (2001) Variability in the bioavailability of Phenytoin capsules in males and females. Pharmaceutical Research, 18, 394-397.
-
(2001)
Pharmaceutical Research
, vol.18
, pp. 394-397
-
-
Meyer, M.C.1
Straughn, A.B.2
Mhatre, R.M.3
Shah, V.P.4
Chen, M.-L.5
Williams, R.L.6
Lesko, L.J.7
-
302
-
-
0027256110
-
Logarithmic transformation in bioequivalence: Application with two formulations of Perphenazine
-
Midha, K.K., Ormsby, E.D., Hubbard, J.W., McKay, G., Hawes, E.M., Gavalas, L., McGilveray, I.J. (1993) Logarithmic transformation in bioequivalence: Application with two formulations of Perphenazine. Journal of Pharmaceutical Sciences, 82, 138-144.
-
(1993)
Journal of Pharmaceutical Sciences
, vol.82
, pp. 138-144
-
-
Midha, K.K.1
Ormsby, E.D.2
Hubbard, J.W.3
McKay, G.4
Hawes, E.M.5
Gavalas, L.6
McGilveray, I.J.7
-
303
-
-
0030692734
-
Individual and average bioequivalence of high variability drugs and drug products
-
Midha, K.K., Rawson, M.J., Hubbard, J.W. (1997a) Individual and average bioequivalence of high variability drugs and drug products. Journal of Pharmaceutical Sciences, 86, 1193-1197.
-
(1997)
Journal of Pharmaceutical Sciences
, vol.86
, pp. 1193-1197
-
-
Midha, K.K.1
Rawson, M.J.2
Hubbard, J.W.3
-
304
-
-
0032055171
-
Bioequivalence:Switchability and scaling
-
Midha, K.K., Rawson, M.J., Hubbard, J.W. (1997b) Bioequivalence:switchability and scaling. European Journal of Pharmaceutical Sciences, 6, 87-91.
-
(1997)
European Journal of Pharmaceutical Sciences
, vol.6
, pp. 87-91
-
-
Midha, K.K.1
Rawson, M.J.2
Hubbard, J.W.3
-
306
-
-
0034932889
-
Gender-based differences in the toxicity of pharmaceuticals - The Food and Drug Administration’s perspective
-
Miller, M. (2001) Gender-based differences in the toxicity of pharmaceuticals - The Food and Drug Administration’s perspective. International Journal of Toxicology, 20, 149-152.
-
(2001)
International Journal of Toxicology
, vol.20
, pp. 149-152
-
-
Miller, M.1
-
308
-
-
0002829661
-
A test for the significance of the difference between two variances in a sample from a bi-variate normal population
-
Morgan, W.A. (1939) A test for the significance of the difference between two variances in a sample from a bi-variate normal population. Biometrika, 31, 13-19.
-
(1939)
Biometrika
, vol.31
, pp. 13-19
-
-
Morgan, W.A.1
-
310
-
-
0027296372
-
Measurement of the QT interval and the risk associated with QT interval prolongation
-
Moss, A. (1993) Measurement of the QT interval and the risk associated with QT interval prolongation. American Journal of Cardiology, 72, 23B-25B.
-
(1993)
American Journal of Cardiology
, vol.72
, pp. 23B-25B
-
-
Moss, A.1
-
312
-
-
0027724856
-
An improvement on commonly used tests in bioequivalence assessment
-
Munk, A. (1993) An improvement on commonly used tests in bioequivalence assessment. Biometrics, 49, 1225-1230.
-
(1993)
Biometrics
, vol.49
, pp. 1225-1230
-
-
Munk, A.1
-
313
-
-
0442309496
-
1-_ equivalence confidence rules for convex alternatives are _/2 tests with applications to the multivariate assessment of bioequivalence
-
Munk, A., Pfluger, R. (1999) 1-_ equivalence confidence rules for convex alternatives are _/2 tests with applications to the multivariate assessment of bioequivalence. Journal of the American Statistical Association, 94, 1311-1319.
-
(1999)
Journal of the American Statistical Association
, vol.94
, pp. 1311-1319
-
-
Munk, A.1
Pfluger, R.2
-
315
-
-
0033961064
-
East-West development:Understanding the usability and acceptance of foreign data in Japan
-
Nagata, R., Fukase, H., Rafizadeh-Kabe, J. (2000) East-West development:Understanding the usability and acceptance of foreign data in Japan. International Journal of Clinical Pharmacology and Therapeutics, 38, 87-92.
-
(2000)
International Journal of Clinical Pharmacology and Therapeutics
, vol.38
, pp. 87-92
-
-
Nagata, R.1
Fukase, H.2
Rafizadeh-Kabe, J.3
-
316
-
-
85052776197
-
Relevance of ethnic factors in global development:Historic overview
-
D’Arcy, PF., Harron, D. eds., Greystone Books
-
Naito, C. (1998a) Relevance of ethnic factors in global development:Historic overview. In Proceedings of the Fourth International Conference on Harmonisation, D’Arcy, PF., Harron, D. eds., Greystone Books.
-
(1998)
Proceedings of the Fourth International Conference on Harmonisation
-
-
Naito, C.1
-
317
-
-
0031770505
-
Ethnic factors in the acceptability of foreign clinical data
-
Naito, C. (1998b) Ethnic factors in the acceptability of foreign clinical data. Drug Information Journal, 32, 1283S-1292S.
-
(1998)
Drug Information Journal
, vol.32
, pp. 1283S-1292S
-
-
Naito, C.1
-
319
-
-
0002092642
-
General approaches to the problem of bioequivalence
-
O’Quigley, J., Baudoin, C. (1988) General approaches to the problem of bioequivalence. The Statistician, 37, 51-58.
-
(1988)
The Statistician
, vol.37
, pp. 51-58
-
-
O’Quigley, J.1
Baudoin, C.2
-
320
-
-
0025148278
-
Continual reassessment method: A practical design for phase 1 studies in cancer
-
O’Quigley, J., Pepe, M., Fisher, L. (1990) Continual reassessment method: A practical design for phase 1 studies in cancer. Biometrics, 46, 33-48.
-
(1990)
Biometrics
, vol.46
, pp. 33-48
-
-
O’Quigley, J.1
Pepe, M.2
Fisher, L.3
-
321
-
-
0006075504
-
A special case of a bi-variate non-central tdistribution
-
Owen, D.B. (1965) A special case of a bi-variate non-central tdistribution. Biometrika, 52, 437-446.
-
(1965)
Biometrika
, vol.52
, pp. 437-446
-
-
Owen, D.B.1
-
322
-
-
0025137182
-
Review of methods and criteria for the evaluation of bioequivalence studies
-
Pabst, G., Jaeger, H. (1990) Review of methods and criteria for the evaluation of bioequivalence studies. European Journal of Clinical Pharmacology, 38, 5-10.
-
(1990)
European Journal of Clinical Pharmacology
, vol.38
, pp. 5-10
-
-
Pabst, G.1
Jaeger, H.2
-
323
-
-
78651023100
-
The non-central _2 and F-distributions and their applications
-
Patnaik, P.B. (1949) The non-central _2 and F-distributions and their applications. Biometrika, 36, 202-232.
-
(1949)
Biometrika
, vol.36
, pp. 202-232
-
-
Patnaik, P.B.1
-
324
-
-
0030017516
-
Bioequivalence assessment of generic drugs: An American point of view
-
Patnaik, R., Lesko, L.J., Chan, K., Williams, R.L. (1996) Bioequivalence assessment of generic drugs: An American point of view. European Journal of Drug Metabolism and Pharmacokinetics, 21, 159-164.
-
(1996)
European Journal of Drug Metabolism and Pharmacokinetics
, vol.21
, pp. 159-164
-
-
Patnaik, R.1
Lesko, L.J.2
Chan, K.3
Williams, R.L.4
-
325
-
-
0030771117
-
Individual bioequivalence-new concepts in the statistical assessment of bioequivalence metrics
-
the FDA Individual Bioequivalence Working Group
-
Patnaik, R.N., Lesko, L.J., Chen, ML., Williams, R.J., and the FDA Individual Bioequivalence Working Group. (1997) Individual bioequivalence-new concepts in the statistical assessment of bioequivalence metrics. Clinical Pharmacokinetics, 33, 1-6.
-
(1997)
Clinical Pharmacokinetics
, vol.33
, pp. 1-6
-
-
Patnaik, R.N.1
Lesko, L.J.2
Chen, M.L.3
Williams, R.J.4
-
326
-
-
0001813268
-
The construction of balanced designs for experiments involving sequences of treatments
-
Patterson, H.D. (1950) The construction of balanced designs for experiments involving sequences of treatments. Biometrika, 39, 32.
-
(1950)
Biometrika
, vol.39
, pp. 32
-
-
Patterson, H.D.1
-
327
-
-
77956889208
-
Recovery of inter-block information when block sizes are unequal
-
Patterson, H.D., Thompson, R. (1971) Recovery of inter-block information when block sizes are unequal. Biometrika, 58, 545-554.
-
(1971)
Biometrika
, vol.58
, pp. 545-554
-
-
Patterson, H.D.1
Thompson, R.2
-
328
-
-
0032720643
-
A novel Bayesian decision procedure for early-phase dose-finding studies
-
Patterson, S., Francis, S., Ireson, M., Webber, D., Whitehead, J. (1999) A novel Bayesian decision procedure for early-phase dose-finding studies. Journal of Biopharmaceutical Statistics, 9, 583-598.
-
(1999)
Journal of Biopharmaceutical Statistics
, vol.9
, pp. 583-598
-
-
Patterson, S.1
Francis, S.2
Ireson, M.3
Webber, D.4
Whitehead, J.5
-
329
-
-
10644271214
-
A review of the development of biostatistical design and analysis techniques for assessing in vivo bioequivalence, Part 1
-
Patterson, S. (2001a) A review of the development of biostatistical design and analysis techniques for assessing in vivo bioequivalence, Part 1. Indian Journal of Pharmaceutical Sciences, 63, 81-100.
-
(2001)
Indian Journal of Pharmaceutical Sciences
, vol.63
, pp. 81-100
-
-
Patterson, S.1
-
330
-
-
10644225653
-
A review of the development of biostatistical design and analysis techniques for assessing in vivo bioequivalence, Part 2
-
Patterson, S. (2001b) A review of the development of biostatistical design and analysis techniques for assessing in vivo bioequivalence, Part 2. Indian Journal of Pharmaceutical Sciences, 63, 169-186.
-
(2001)
Indian Journal of Pharmaceutical Sciences
, vol.63
, pp. 169-186
-
-
Patterson, S.1
-
331
-
-
0035524171
-
Non-traditional study designs to demonstrate average bioequivalence for highly variable drug products
-
Patterson, S., Zariffa, N., Howland, K., Montague, T. (2001c) Non-traditional study designs to demonstrate average bioequivalence for highly variable drug products. European Journal of Clinical Pharmacology, 57, 663-670.
-
(2001)
European Journal of Clinical Pharmacology
, vol.57
, pp. 663-670
-
-
Patterson, S.1
Zariffa, N.2
Howland, K.3
Montague, T.4
-
332
-
-
10644254023
-
Bioequivalence and the pharmaceutical industry
-
Patterson, S., Jones, B. (2002a) Bioequivalence and the pharmaceutical industry. Pharmaceutical Statistics, 1, 83-95.
-
(2002)
Pharmaceutical Statistics
, vol.1
, pp. 83-95
-
-
Patterson, S.1
Jones, B.2
-
334
-
-
85052767442
-
Clinical development planning and the use of pharmacokinetic data in ICH-E5 bridging assessments
-
Patterson, S., Jones, B. (2002c) Clinical development planning and the use of pharmacokinetic data in ICH-E5 bridging assessments. GSK BDS Technical Report 2002-04.
-
(2002)
GSK BDS Technical Report 2002-04
-
-
Patterson, S.1
Jones, B.2
-
335
-
-
10644255729
-
Simulation assessments of statistical aspects of bioequivalence in the pharmaceutical industry
-
Patterson, S., Jones, B. (2004a) Simulation assessments of statistical aspects of bioequivalence in the pharmaceutical industry. Pharmaceutical Statistics, 3, 13-23.
-
(2004)
Pharmaceutical Statistics
, vol.3
, pp. 13-23
-
-
Patterson, S.1
Jones, B.2
-
336
-
-
19944401619
-
Investigating Drug Induced QT and QTc Prolongation in the Clinic: Statistical Design and Analysis Considerations
-
(In Press)
-
Patterson, S., Agin, M., Anziano, R., Chuang-Stein, C., Dmitrienko, A., Ferber, G., Francom, S., Geraldes, M., Ghosh, K., Mills, T., Menton, R., Natarajan, J., Offen, W., Saoud, J., Smith, B., Suresh, R., Zariffa, N. (In Press) Investigating Drug Induced QT and QTc Prolongation in the Clinic: Statistical Design and Analysis Considerations. Drug Information Journal.
-
Drug Information Journal
-
-
Patterson, S.1
Agin, M.2
Anziano, R.3
Chuang-Stein, C.4
Dmitrienko, A.5
Ferber, G.6
Francom, S.7
Geraldes, M.8
Ghosh, K.9
Mills, T.10
Menton, R.11
Natarajan, J.12
Offen, W.13
Saoud, J.14
Smith, B.15
Suresh, R.16
Zariffa, N.17
-
337
-
-
18344373549
-
Estimating the degree of equivalence and nonequivalence, an alternative to bioequivalence testing
-
Peace, K.E. (1986) Estimating the degree of equivalence and nonequivalence, an alternative to bioequivalence testing. Proceedings of the American Statistical Association, 63-69.
-
(1986)
Proceedings of the American Statistical Association
, pp. 63-69
-
-
Peace, K.E.1
-
339
-
-
0006543279
-
Design and analysis considerations for safety data, particularly adverse events
-
Gibert, G.S. ed, Marcel Dekker, New York
-
Peace, K.E. (1993) Design and analysis considerations for safety data, particularly adverse events. In Drug Safety Assessment in Clinical Trials, Gibert, G.S. ed., 305-316. Marcel Dekker, New York.
-
(1993)
Drug Safety Assessment in Clinical Trials
, pp. 305-316
-
-
Peace, K.E.1
-
340
-
-
0003167589
-
Simulation of clinical trials: Encouragements and cautions
-
Peck, C., Desjardins, R. (1996) Simulation of clinical trials: Encouragements and cautions. Applied Clinical Trials, 30-32.
-
(1996)
Applied Clinical Trials
, pp. 30-32
-
-
Peck, C.1
Desjardins, R.2
-
341
-
-
0025334006
-
Power of the two one-sided testing procedure in bioequivalence
-
Phillips, K.F. (1990) Power of the two one-sided testing procedure in bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics, 18, 137-144.
-
(1990)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.18
, pp. 137-144
-
-
Phillips, K.F.1
-
342
-
-
0002363710
-
A note on normal correlation
-
Pitman, E.C.G. (1939) A note on normal correlation. Biometrika, 31, 9-12.
-
(1939)
Biometrika
, vol.31
, pp. 9-12
-
-
Pitman, E.C.G.1
-
343
-
-
0017744944
-
Group sequential methods in the design and analysis of clinical trials
-
Pocock, S.J. (1977) Group sequential methods in the design and analysis of clinical trials. Biometrics, 64, 191-199.
-
(1977)
Biometrics
, vol.64
, pp. 191-199
-
-
Pocock, S.J.1
-
345
-
-
33748980278
-
Role of interoccasion variation in estimation of bioequivalence: A Bayesian approach
-
Pradhan, R.S. (1997) Role of interoccasion variation in estimation of bioequivalence: A Bayesian approach. Clinical Pharmacology and Therapeutics, 61, 186.
-
(1997)
Clinical Pharmacology and Therapeutics
, vol.61
, pp. 186
-
-
Pradhan, R.S.1
-
346
-
-
0028082462
-
Risk of developing life-threatening ventricular arrhythmia associated with terfenadine in comparison with other over the counter antihistamines
-
Pratt, C., Hertz, R., Elis, B., Crowell, S., Louv, W., Moye, L. (1994) Risk of developing life-threatening ventricular arrhythmia associated with terfenadine in comparison with other over the counter antihistamines. American Journal of Cardiology, 73, 346-352.
-
(1994)
American Journal of Cardiology
, vol.73
, pp. 346-352
-
-
Pratt, C.1
Hertz, R.2
Elis, B.3
Crowell, S.4
Louv, W.5
Moye, L.6
-
347
-
-
0029883856
-
Dose-response relation between terfenadine (Seldane) and the QTc interval on the scalar electrocardiogram: Distinguishing drug effect from spontaneous variability
-
Pratt, C., Ruberg, S., Morganroth, J., McNutt, B., Woodward, J., Harris, S., Ruskin, J., Moye, L. (1996) Dose-response relation between terfenadine (Seldane) and the QTc interval on the scalar electrocardiogram: Distinguishing drug effect from spontaneous variability. American Heart Journal, 131, 472-480.
-
(1996)
American Heart Journal
, vol.131
, pp. 472-480
-
-
Pratt, C.1
Ruberg, S.2
Morganroth, J.3
McNutt, B.4
Woodward, J.5
Harris, S.6
Ruskin, J.7
Moye, L.8
-
348
-
-
0024520844
-
Surrogate endpoints in clinical trials: Definition and operational criteria
-
Prentice, R. (1989) Surrogate endpoints in clinical trials: Definition and operational criteria. Statistics in Medicine, 8, 431-440.
-
(1989)
Statistics in Medicine
, vol.8
, pp. 431-440
-
-
Prentice, R.1
-
349
-
-
0038415858
-
Risk stratification in the long-QT syndrome
-
Priori, S., Schwartz, P., Napolitano, C., Bloise, R., Ronchetti, E., Grillo, M., Vicentini, A., Spazzolini, C., Nastoli, J., Bottelli, G., Folli, R., Capelletti, D. (2003) Risk stratification in the long-QT syndrome. New England Journal of Medicine, 348, 1866-1874.
-
(2003)
New England Journal of Medicine
, vol.348
, pp. 1866-1874
-
-
Priori, S.1
Schwartz, P.2
Napolitano, C.3
Bloise, R.4
Ronchetti, E.5
Grillo, M.6
Vicentini, A.7
Spazzolini, C.8
Nastoli, J.9
Bottelli, G.10
Folli, R.11
Capelletti, D.12
-
350
-
-
0037100219
-
Alternative confidence intervals for the assessment of bioequivalence in fourperiod cross-over designs
-
Quiroz, J., Ting, N., Wei, G., Burdick, R. (2002) Alternative confidence intervals for the assessment of bioequivalence in fourperiod cross-over designs. Statistics in Medicine, 21, 1825-1847.
-
(2002)
Statistics in Medicine
, vol.21
, pp. 1825-1847
-
-
Quiroz, J.1
Ting, N.2
Wei, G.3
Burdick, R.4
-
351
-
-
0002008937
-
Bayesian methods in practice, experiences in the pharmaceutical industry (with discussion)
-
Racine-Poon, A., Grieve, A.P., Fluhler, H., Smith, A. F-M. (1986) Bayesian methods in practice, experiences in the pharmaceutical industry (with discussion). Applied Statistics, 35, 93-150.
-
(1986)
Applied Statistics
, vol.35
, pp. 93-150
-
-
Racine-Poon, A.1
Grieve, A.P.2
Fluhler, H.3
Smith, A.F.-M.4
-
352
-
-
0023580164
-
A two-stage procedure for bioequivalence studies
-
Racine-Poon, A., Grieve, A.P., Fluhler, H., Smith, A. F-M. (1987) A two-stage procedure for bioequivalence studies. Biometrics, 43, 847-856.
-
(1987)
Biometrics
, vol.43
, pp. 847-856
-
-
Racine-Poon, A.1
Grieve, A.P.2
Fluhler, H.3
Smith, A.F.-M.4
-
353
-
-
85052776334
-
The clinical evaluation of QT interval prolongation and proarrythmic potential for non-antiarrythmic Drugs
-
Racoosin, J. (2003) The clinical evaluation of QT interval prolongation and proarrythmic potential for non-antiarrythmic Drugs. Presentation at Drug Information Agency/FDA Workshop, www.diahome.org
-
(2003)
Presentation at Drug Information Agency/FDA Workshop
-
-
Racoosin, J.1
-
355
-
-
0030849120
-
An evaluation of the integration of pharmacokinetic and pharmacodynmaic principles in clinical drug development
-
Reigner, B., Williams, P., Patel, I., Steimer, J., Peck, C., Brummelen, P. (1997) An evaluation of the integration of pharmacokinetic and pharmacodynmaic principles in clinical drug development. Clinical Pharmacokinetics, 33, 142-152.
-
(1997)
Clinical Pharmacokinetics
, vol.33
, pp. 142-152
-
-
Reigner, B.1
Williams, P.2
Patel, I.3
Steimer, J.4
Peck, C.5
Brummelen, P.6
-
356
-
-
0035723305
-
Estimating the starting dose for entry into humans: Principles and practice
-
Reigner, B., Blesch, K. (2001) Estimating the starting dose for entry into humans: principles and practice. European Journal of Clinical Pharmacology, 57, 835-845.
-
(2001)
European Journal of Clinical Pharmacology
, vol.57
, pp. 835-845
-
-
Reigner, B.1
Blesch, K.2
-
357
-
-
0022758747
-
Statistical inference for Pr(Y < X)
-
Reiser, B., Guttman, I. (1986) Statistical inference for Pr(Y < X). Technometrics, 28, 253-257.
-
(1986)
Technometrics
, vol.28
, pp. 253-257
-
-
Reiser, B.1
Guttman, I.2
-
359
-
-
0031987387
-
AUC and Cmax are not sufficient to prove bioequivalence
-
Rescigno, A., Powers, J.D. (1998) AUC and Cmax are not sufficient to prove bioequivalence. Pharmacological Research, 37, 93-95.
-
(1998)
Pharmacological Research
, vol.37
, pp. 93-95
-
-
Rescigno, A.1
Powers, J.D.2
-
360
-
-
0025357494
-
Therapeutic inequivalence
-
Rheinstein, P.H. (1990) Therapeutic inequivalence. Drug Safety 5, Suppl 1, 114-119.
-
(1990)
Drug Safety
, vol.5
, pp. 114-119
-
-
Rheinstein, P.H.1
-
362
-
-
0034047307
-
Sensitivity of empirical metrics of rate of absorption in bioequivalence studies
-
Ring, A., Tothfalusi, L., Endrenyi, L., Weiss, M. (2000) Sensitivity of empirical metrics of rate of absorption in bioequivalence studies. Pharmaceutical Research, 17, 583-588.
-
(2000)
Pharmaceutical Research
, vol.17
, pp. 583-588
-
-
Ring, A.1
Tothfalusi, L.2
Endrenyi, L.3
Weiss, M.4
-
363
-
-
0021397596
-
On testing for bioequivalence
-
Rocke, D.M. (1984) On testing for bioequivalence. Biometrics, 40, 225-230.
-
(1984)
Biometrics
, vol.40
, pp. 225-230
-
-
Rocke, D.M.1
-
364
-
-
0018976518
-
Determining the probability of an important difference in bioavailability
-
Rodda, B.E., Davis R.L. (1980) Determining the probability of an important difference in bioavailability. Clinical Pharmacology and Therapeutics, 28, 247-252.
-
(1980)
Clinical Pharmacology and Therapeutics
, vol.28
, pp. 247-252
-
-
Rodda, B.E.1
Davis, R.L.2
-
365
-
-
0030970645
-
Comparison of population pharmacokinetic modelling methods using simulated data: Results from the Population Modelling Workgroup
-
Roe, D., Vonesh, E., Wolfinger, R., Mensil, F., Mallet, A. (1997) Comparison of population pharmacokinetic modelling methods using simulated data: Results from the Population Modelling Workgroup. Statistics in Medicine, 16, 1241-1262.
-
(1997)
Statistics in Medicine
, vol.16
, pp. 1241-1262
-
-
Roe, D.1
Vonesh, E.2
Wolfinger, R.3
Mensil, F.4
Mallet, A.5
-
367
-
-
0036374957
-
Bridging data between two ethnic populations. A new application of matched case-control methodology
-
Sarkar, S., Watts, S., Ohashi, O., Carroll, R., Uesaka, H., Mason, T., Rivera, C. (2002) Bridging data between two ethnic populations. A new application of matched case-control methodology. Drug Information Journal, 36, 349-356.
-
(2002)
Drug Information Journal
, vol.36
, pp. 349-356
-
-
Sarkar, S.1
Watts, S.2
Ohashi, O.3
Carroll, R.4
Uesaka, H.5
Mason, T.6
Rivera, C.7
-
369
-
-
0000841881
-
Synthesis of variance
-
Satterthwaite, F. (1941) Synthesis of variance. Psychometrika, 6, 309-316.
-
(1941)
Psychometrika
, vol.6
, pp. 309-316
-
-
Satterthwaite, F.1
-
370
-
-
0029083127
-
Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar
-
Schall, R. (1995) Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar. Biometrics, 51, 615-626.
-
(1995)
Biometrics
, vol.51
, pp. 615-626
-
-
Schall, R.1
-
371
-
-
0027244039
-
On population and individual bioequivalence
-
Schall, R., Luus, H.G. (1993) On population and individual bioequivalence. Statistics in Medicine, 12, 1109-1124.
-
(1993)
Statistics in Medicine
, vol.12
, pp. 1109-1124
-
-
Schall, R.1
Luus, H.G.2
-
373
-
-
0000120766
-
Estimating the dimension of a model
-
Schwarz, G. (1978) Estimating the dimension of a model. The Annals of Statistics, 6(2), 461-464.
-
(1978)
The Annals of Statistics
, vol.6
, Issue.2
, pp. 461-464
-
-
Schwarz, G.1
-
374
-
-
0000117116
-
On hypothesis testing to determine if the mean of a normal distribution is contained in a known interval
-
Schuirmann, D.J. (1981) On hypothesis testing to determine if the mean of a normal distribution is contained in a known interval. Biometrics, 37, 617.
-
(1981)
Biometrics
, vol.37
, pp. 617
-
-
Schuirmann, D.J.1
-
375
-
-
0023615056
-
A comparison of the two one sided tests procedure and the power approach for assessing the equivalence of average bioavailability
-
Schuirmann, D.J. (1987) A comparison of the two one sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics, 15, 657-680.
-
(1987)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.15
, pp. 657-680
-
-
Schuirmann, D.J.1
-
376
-
-
0025065421
-
Design of bioavailability and bioequivalence studies
-
Schuirmann, D.J. (1990) Design of bioavailability and bioequivalence studies. Drug Information Journal, 24, 315-323.
-
(1990)
Drug Information Journal
, vol.24
, pp. 315-323
-
-
Schuirmann, D.J.1
-
378
-
-
0031795947
-
The phenytoin trial is a case study of individual bioequivalence
-
Schumaker, R.C., Metzler, C.M. (1998) The phenytoin trial is a case study of individual bioequivalence. Drug Information Journal, 32, 1063-1072.
-
(1998)
Drug Information Journal
, vol.32
, pp. 1063-1072
-
-
Schumaker, R.C.1
Metzler, C.M.2
-
379
-
-
0004242197
-
-
John Wiley and Sons, New York
-
Searle, S.R. (1971) Linear Models. John Wiley and Sons, New York.
-
(1971)
Linear Models
-
-
Searle, S.R.1
-
381
-
-
0019541686
-
A Bayesian approach to bioequivalence for the 2 × 2 cross-over design
-
Selwyn, M.R., Dempster, A.P., Hall, N.R. (1981) A Bayesian approach to bioequivalence for the 2 × 2 cross-over design. Biometrics, 37, 11-21.
-
(1981)
Biometrics
, vol.37
, pp. 11-21
-
-
Selwyn, M.R.1
Dempster, A.P.2
Hall, N.R.3
-
382
-
-
0021702745
-
On Bayesian methods for bioequivalence
-
Selwyn, M.R., Hall, N.R. (1984) On Bayesian methods for bioequivalence. Biometrics, 40, 1103-1108.
-
(1984)
Biometrics
, vol.40
, pp. 1103-1108
-
-
Selwyn, M.R.1
Hall, N.R.2
-
383
-
-
0003123095
-
The AB/BA cross-over: How to perform the twostage analysis if you can’t be persuaded you shouldn’t
-
Hansen, B., and de Ridder, M. eds, Erasmus University, Rotterdam
-
Senn, S. (1996) The AB/BA cross-over: How to perform the twostage analysis if you can’t be persuaded you shouldn’t. In Liber Amicorum Roel van Strik, Hansen, B., and de Ridder, M. eds., 93-100. Erasmus University, Rotterdam.
-
(1996)
Liber Amicorum Roel van Strik
, pp. 93-100
-
-
Senn, S.1
-
385
-
-
0032508256
-
In the blood: Proposed new requirements for registering generic drugs
-
Senn, S. (1998) In the blood: Proposed new requirements for registering generic drugs. The Lancet, 352, 85-86.
-
(1998)
The Lancet
, vol.352
, pp. 85-86
-
-
Senn, S.1
-
387
-
-
0035884236
-
Statistical issues in bioequivalence
-
Senn, S. (2001) Statistical issues in bioequivalence. Statistics in Medicine, 20, 2785-2799.
-
(2001)
Statistics in Medicine
, vol.20
, pp. 2785-2799
-
-
Senn, S.1
-
389
-
-
10644225341
-
The analysis of the AB/BA cross-over trial in the medical literature
-
Senn, S., Lee, S. (2004a) The analysis of the AB/BA cross-over trial in the medical literature. Pharmaceutical Statistics, 3, 123-131.
-
(2004)
Pharmaceutical Statistics
, vol.3
, pp. 123-131
-
-
Senn, S.1
Lee, S.2
-
390
-
-
10644257506
-
Carry-over in crossover trials in bioequivalence: Theoretical concerns and empirical evidence
-
Senn, S., D’Angelo, G., Potvin, D. (2004b) Carry-over in crossover trials in bioequivalence: Theoretical concerns and empirical evidence. Pharmaceutical Statistics, 3, 133-142.
-
(2004)
Pharmaceutical Statistics
, vol.3
, pp. 133-142
-
-
Senn, S.1
D’Angelo, G.2
Potvin, D.3
-
392
-
-
84890829458
-
Modified Sequentially Rejective Multiple Test Procedures
-
Shaffer, J. (1986) Modified Sequentially Rejective Multiple Test Procedures. Journal of the American Statistical Association, 81, 826-831.
-
(1986)
Journal of the American Statistical Association
, vol.81
, pp. 826-831
-
-
Shaffer, J.1
-
393
-
-
17444453579
-
Workshop report:Evaluation of orally administered highly variable drugs and drug formulations
-
Shah, V.P., Yacobi, A., Barr, W., Benet, L.Z., Breimer, D., Dobrinska, M.R., Endrenyi, L., Fairweather, W., Gillespie, W., Gonzalez, M.A., Hooper, J., Jackson, A., Lesko, L.J., Midha, K.K., Noonan, P.K., Patnaik, R., Williams, R.L. (1996) Workshop report:Evaluation of orally administered highly variable drugs and drug formulations. Pharmaceutical Research, 13, 1590-1594.
-
(1996)
Pharmaceutical Research
, vol.13
, pp. 1590-1594
-
-
Shah, V.P.1
Yacobi, A.2
Barr, W.3
Benet, L.Z.4
Breimer, D.5
Dobrinska, M.R.6
Endrenyi, L.7
Fairweather, W.8
Gillespie, W.9
Gonzalez, M.A.10
Hooper, J.11
Jackson, A.12
Lesko, L.J.13
Midha, K.K.14
Noonan, P.K.15
Patnaik, R.16
Williams, R.L.17
-
395
-
-
0034735584
-
The bootstrap procedure in individual bioequivalence
-
Shao, J., Chow, S.-C., Wang, B. (2000a) The bootstrap procedure in individual bioequivalence. Statistics in Medicine, 19, 2741-2754.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2741-2754
-
-
Shao, J.1
Chow, S.-C.2
Wang, B.3
-
396
-
-
0000010050
-
Consistency of the bootstrap procedure in individual bioequivalence
-
Shao, J., Kubler, J., Pigeot, I. (2000b) Consistency of the bootstrap procedure in individual bioequivalence. Biometrika, 87, 573-585.
-
(2000)
Biometrika
, vol.87
, pp. 573-585
-
-
Shao, J.1
Kubler, J.2
Pigeot, I.3
-
397
-
-
0000898845
-
An analysis of variance test for normality (complete samples)
-
Shapiro, S., Wilk, M. (1965). An analysis of variance test for normality (complete samples). Biometrika, 52, 591-611.
-
(1965)
Biometrika
, vol.52
, pp. 591-611
-
-
Shapiro, S.1
Wilk, M.2
-
398
-
-
4444356502
-
A convenient five-drug cocktail for the assessment of major drug metabolizing enzymes: A pilot study
-
Sharma, A., Pilote, S., Belanger, P., Arsenault, M., Hamelin, B. (2004). A convenient five-drug cocktail for the assessment of major drug metabolizing enzymes: A pilot study, British Journal of Clinical Pharmacology, 58, 288-297.
-
(2004)
British Journal of Clinical Pharmacology
, vol.58
, pp. 288-297
-
-
Sharma, A.1
Pilote, S.2
Belanger, P.3
Arsenault, M.4
Hamelin, B.5
-
399
-
-
0024354917
-
Study designs for dose-ranging
-
Sheiner L.B., Beal, S.L., Sambol, N.C. (1989) Study designs for dose-ranging. Clinical Pharmacology and Therapeutics, 46, 63-77.
-
(1989)
Clinical Pharmacology and Therapeutics
, vol.46
, pp. 63-77
-
-
Sheiner, L.B.1
Beal, S.L.2
Sambol, N.C.3
-
400
-
-
0026087226
-
A simulation study comparing designs for dose ranging
-
Sheiner, L.B., Hashimoto, Y., Beal, S. (1991) A simulation study comparing designs for dose ranging. Statistics in Medicine, 10, 303-321.
-
(1991)
Statistics in Medicine
, vol.10
, pp. 303-321
-
-
Sheiner, L.B.1
Hashimoto, Y.2
Beal, S.3
-
401
-
-
0026481178
-
Bioequivalence revisited
-
Sheiner, L.B. (1992) Bioequivalence revisited. Statistics in Medicine, 11, 1777-1788.
-
(1992)
Statistics in Medicine
, vol.11
, pp. 1777-1788
-
-
Sheiner, L.B.1
-
402
-
-
0031003468
-
Learning versus confirming in clinical drug development
-
Sheiner, L.B. (1997) Learning versus confirming in clinical drug development. Clinical Pharmacology and Therapeutics, 61, 275-291.
-
(1997)
Clinical Pharmacology and Therapeutics
, vol.61
, pp. 275-291
-
-
Sheiner, L.B.1
-
403
-
-
0034119297
-
Pharmacokinetic-Pharmacodynamic Modeling in Drug Development
-
Sheiner, L.B., Steimer, J-L. (2000) Pharmacokinetic-Pharmacodynamic Modeling in Drug Development. Annu. Rev. Pharmacol. Toxicol., 40, 67-95.
-
(2000)
Annu. Rev. Pharmacol. Toxicol.
, vol.40
, pp. 67-95
-
-
Sheiner, L.B.1
Steimer, J.-L.2
-
404
-
-
0034882176
-
Clinical trials for drug registrations in Asian-Pacific countries: Proposal for a new paradigm from a statistical perspective
-
Shih, W. (2001) Clinical trials for drug registrations in Asian-Pacific countries: Proposal for a new paradigm from a statistical perspective. Controlled Clinical Trials, 22, 357-366.
-
(2001)
Controlled Clinical Trials
, vol.22
, pp. 357-366
-
-
Shih, W.1
-
405
-
-
0032698154
-
Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling
-
Singh, G.J.-P., Adams, W.P., Lesko, L.J., Shah, V.P., Molzon, J.A., Williams, R.L., Pershing, L.K. (1999) Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling. Clinical Pharmacology and Therapeutics, 66, 346-357.
-
(1999)
Clinical Pharmacology and Therapeutics
, vol.66
, pp. 346-357
-
-
Singh, G.J.-P.1
Adams, W.P.2
Lesko, L.J.3
Shah, V.P.4
Molzon, J.A.5
Williams, R.L.6
Pershing, L.K.7
-
406
-
-
0033634992
-
Confidence interval criteria for assessment of dose proportionality
-
Smith, B., Vandenhende, F., DeSante, K., Farid, N., Welch, P., Callaghan, J., Forgue, S. (2000) Confidence interval criteria for assessment of dose proportionality. Pharmaceutical Research, 17, 1278-1283.
-
(2000)
Pharmaceutical Research
, vol.17
, pp. 1278-1283
-
-
Smith, B.1
Vandenhende, F.2
DeSante, K.3
Farid, N.4
Welch, P.5
Callaghan, J.6
Forgue, S.7
-
407
-
-
34250632705
-
Software for non-linear mixed effects modelling:A review of several packages
-
Smith, M. (2003) Software for non-linear mixed effects modelling:a review of several packages. Pharmaceutical Statistics, 2, 69-75.
-
(2003)
Pharmaceutical Statistics
, vol.2
, pp. 69-75
-
-
Smith, M.1
-
408
-
-
66749169833
-
Assessment of Dose Proportionality
-
Bonate, P., Howard, D., eds, AAPS Press, USA
-
Smith, B. (2004) Assessment of Dose Proportionality. In Pharmacokinetics in Drug Development: Clinical Study Design and Analysis, Volume 1, Bonate, P., Howard, D., eds., 363-382. AAPS Press, USA.
-
(2004)
Pharmacokinetics in Drug Development: Clinical Study Design and Analysis, Volume 1
, pp. 363-382
-
-
Smith, B.1
-
409
-
-
0027932485
-
A two step method for assessing bioequivalence
-
Snikeris, F., Tingey, H.B. (1994) A two step method for assessing bioequivalence. Drug Information Journal, 28, 709-722.
-
(1994)
Drug Information Journal
, vol.28
, pp. 709-722
-
-
Snikeris, F.1
Tingey, H.B.2
-
410
-
-
0033810627
-
Dissolution and in vivo evidence of differences in reference products: Impact on development of generic drugs
-
Spino, M., Tsang, Y.C., Pop, R. (2000) Dissolution and in vivo evidence of differences in reference products: Impact on development of generic drugs. European Journal of Drug Metabolism and Pharmacokinetics, 25, 18-24.
-
(2000)
European Journal of Drug Metabolism and Pharmacokinetics
, vol.25
, pp. 18-24
-
-
Spino, M.1
Tsang, Y.C.2
Pop, R.3
-
411
-
-
0037374186
-
Importance of high density lipoprotein cholesterol and triglyceride levels in coronary heart disease
-
Sprecher, D., Watkins, T., Behar, S., Brown, W., Rubins, H., Schaefer, E. (2003) Importance of high density lipoprotein cholesterol and triglyceride levels in coronary heart disease. The American Journal of Cardiology, 91, 575-580.
-
(2003)
The American Journal of Cardiology
, vol.91
, pp. 575-580
-
-
Sprecher, D.1
Watkins, T.2
Behar, S.3
Brown, W.4
Rubins, H.5
Schaefer, E.6
-
412
-
-
84981976338
-
A two-stage procedure with controlled error probabilities for testing equivalence
-
Srinivasan, R, Langenberg, P. (1986) A two-stage procedure with controlled error probabilities for testing equivalence. Biometrical Journal, 7, 825-833.
-
(1986)
Biometrical Journal
, vol.7
, pp. 825-833
-
-
Srinivasan, R.1
Langenberg, P.2
-
413
-
-
85151679662
-
-
25th ed, William and Wilkins, Baltimore
-
Stedman’s Medical Dictionary, 25th ed. (1990) William and Wilkins, Baltimore.
-
(1990)
-
-
-
414
-
-
0020662337
-
Statistical analysis of bioavailability studies: Parametric and nonparametric confidence interval
-
Steinijans, V.W., Diletti, E. (1983) Statistical analysis of bioavailability studies: Parametric and nonparametric confidence interval. European Journal of Clinical Pharmacology, 24, 127-136.
-
(1983)
European Journal of Clinical Pharmacology
, vol.24
, pp. 127-136
-
-
Steinijans, V.W.1
Diletti, E.2
-
415
-
-
0025358452
-
Update on the statistical analysis of bioequivalence studies
-
Steinijans, V.W., Hauschke, V. (1990) Update on the statistical analysis of bioequivalence studies. International Journal of Clinicial Pharmacology, Therapy, and Toxicology, 28, 105-110.
-
(1990)
International Journal of Clinicial Pharmacology, Therapy, and Toxicology
, vol.28
, pp. 105-110
-
-
Steinijans, V.W.1
Hauschke, V.2
-
416
-
-
0025859676
-
Lack of pharmacokinetic interaction as an equivalence problem
-
Steinijans, V.W., Hartmann, M., Huber, R., Radtke, H.W. (1991) Lack of pharmacokinetic interaction as an equivalence problem. International Journal of Clinicial Pharmacology, Therapy, and Toxicology, 29, 323-328.
-
(1991)
International Journal of Clinicial Pharmacology, Therapy, and Toxicology
, vol.29
, pp. 323-328
-
-
Steinijans, V.W.1
Hartmann, M.2
Huber, R.3
Radtke, H.W.4
-
417
-
-
0029100508
-
Metrics to characterize concentration-time profiles in single and multiple-dose bioequivalence studies
-
Steinijans, V.W., Sauter, R., Hauschke, D., Elze, M. (1995) Metrics to characterize concentration-time profiles in single and multiple-dose bioequivalence studies. Drug Information Journal, 29, 981-987.
-
(1995)
Drug Information Journal
, vol.29
, pp. 981-987
-
-
Steinijans, V.W.1
Sauter, R.2
Hauschke, D.3
Elze, M.4
-
418
-
-
0029132048
-
International harmonization of regulatory requirements for average bioequivalence and current issues in individual bioequivalence
-
Steinijans, V.W., Hauschke, D., Schall, R. (1995) International harmonization of regulatory requirements for average bioequivalence and current issues in individual bioequivalence. Drug Information Journal, 29, 1055-1062.
-
(1995)
Drug Information Journal
, vol.29
, pp. 1055-1062
-
-
Steinijans, V.W.1
Hauschke, D.2
Schall, R.3
-
420
-
-
0003526332
-
-
SAS Institute, Cary, NC
-
Stokes, M., Davis, C., Koch, G. (2002) Categorical Data Analysis Using the SAS System. SAS Institute, Cary, NC.
-
(2002)
Categorical Data Analysis Using the SAS System
-
-
Stokes, M.1
Davis, C.2
Koch, G.3
-
421
-
-
0023226178
-
Generic drug substitution revisited
-
Strom, B.L. (1987) Generic drug substitution revisited. NEJM, 316, 1456-1462.
-
(1987)
NEJM
, vol.316
, pp. 1456-1462
-
-
Strom, B.L.1
-
422
-
-
85052767586
-
Points to notice and proposal drug induced QT interval prolongation - Is your correction good enough?
-
Suganami, H. (2004) Points to notice and proposal drug induced QT interval prolongation - Is your correction good enough? Drug Information Association Meeting, www.diahome.org
-
(2004)
Drug Information Association Meeting
-
-
Suganami, H.1
-
423
-
-
0021375677
-
Monte carlo comparison of ANOVA, MIVQUE, REML, and ML estimators of variance components
-
Swallow, W., Monahan, J. (1984) Monte carlo comparison of ANOVA, MIVQUE, REML, and ML estimators of variance components. Technometrics, 26, 47-57.
-
(1984)
Technometrics
, vol.26
, pp. 47-57
-
-
Swallow, W.1
Monahan, J.2
-
424
-
-
0036189226
-
Ethical considerations for clinical trials in Asia
-
Tanida, N. (2002) Ethical considerations for clinical trials in Asia. Drug Information Journal, 36, 41-9.
-
(2002)
Drug Information Journal
, vol.36
, pp. 41-49
-
-
Tanida, N.1
-
425
-
-
0033603814
-
Are surrogate markers adequate to assess cardiovascular disease drugs?
-
Temple, R. (1999) Are surrogate markers adequate to assess cardiovascular disease drugs? Journal of the American Medical Association, 282, 790-795.
-
(1999)
Journal of the American Medical Association
, vol.282
, pp. 790-795
-
-
Temple, R.1
-
426
-
-
45949098378
-
Overview of the concept paper, history of the QT/TdP concern; Regulatory implications of QT prolongation
-
Temple, R. (2003) Overview of the concept paper, history of the QT/TdP concern; Regulatory implications of QT prolongation. Presentations at Drug Information Agency/FDA Workshop, www.diahome.org
-
(2003)
Presentations at Drug Information Agency/FDA Workshop
-
-
Temple, R.1
-
427
-
-
4444272419
-
Dose-finding based on efficacy-toxicity trade-offs
-
Thall, P., Cook, J. (2004) Dose-finding based on efficacy-toxicity trade-offs. Biometrics, 60, 684-693.
-
(2004)
Biometrics
, vol.60
, pp. 684-693
-
-
Thall, P.1
Cook, J.2
-
428
-
-
0002068388
-
Confidence intervals on linear combinations of variance components that are unrestricted in sign
-
Ting, N., Burdick, R.K., Graybill, F.A., Jeyaratnam, S., Lu, TF. C. (1990) Confidence intervals on linear combinations of variance components that are unrestricted in sign. Journal of Statistical Computing and Simulation, 35, 135-143.
-
(1990)
Journal of Statistical Computing and Simulation
, vol.35
, pp. 135-143
-
-
Ting, N.1
Burdick, R.K.2
Graybill, F.A.3
Jeyaratnam, S.4
Lu, T.F.C.5
-
429
-
-
0034865996
-
Evaluation of the bioequivalence of highly-variable drugs and drug products
-
Tothfalusi, L., Endrenyi, L., Midha, K., Rawson, M., Hubbard, J. (2001) Evaluation of the bioequivalence of highly-variable drugs and drug products. Pharmaceutical Research, 18, 728-733.
-
(2001)
Pharmaceutical Research
, vol.18
, pp. 728-733
-
-
Tothfalusi, L.1
Endrenyi, L.2
Midha, K.3
Rawson, M.4
Hubbard, J.5
-
430
-
-
0037337782
-
Limits for the scaled average bioequivalence of highly variable drugs and drug products
-
Tothfalusi, L., Endrenyi, L. (2003) Limits for the scaled average bioequivalence of highly variable drugs and drug products. Pharmaceutical Research, 20, 382-389.
-
(2003)
Pharmaceutical Research
, vol.20
, pp. 382-389
-
-
Tothfalusi, L.1
Endrenyi, L.2
-
431
-
-
0029940802
-
Absorption rate versus exposure: Which is more useful for bioequivalence testing?
-
Tozer, T.N., Bois, F.Y., Hauck, W.W., Chen, M.L., Williams, R.L. (1996) Absorption rate versus exposure: Which is more useful for bioequivalence testing? Pharmaceutical Research, 13, 453-456.
-
(1996)
Pharmaceutical Research
, vol.13
, pp. 453-456
-
-
Tozer, T.N.1
Bois, F.Y.2
Hauck, W.W.3
Chen, M.L.4
Williams, R.L.5
-
432
-
-
0030611077
-
Cmax/AUC, a commentary
-
Tozer, T.N., Hauck, W.W. (1997) Cmax/AUC, a commentary. Pharmaceutical Research, 14, 967-968.
-
(1997)
Pharmaceutical Research
, vol.14
, pp. 967-968
-
-
Tozer, T.N.1
Hauck, W.W.2
-
433
-
-
0029942944
-
High variability in drug pharmacokinetics complicates determination of bioequivalence: Experience with Verapamil
-
Tsang, Y.C., Opo, R., Gordon, P., Hems, J., Spino, M. (1996) High variability in drug pharmacokinetics complicates determination of bioequivalence: Experience with Verapamil. Pharmaceutical Research, 13, 846-850.
-
(1996)
Pharmaceutical Research
, vol.13
, pp. 846-850
-
-
Tsang, Y.C.1
Opo, R.2
Gordon, P.3
Hems, J.4
Spino, M.5
-
434
-
-
0028691960
-
Review of nonparametric methods for the analysis of crossover studies
-
Tudor, G., Koch, G. (1994) Review of nonparametric methods for the analysis of crossover studies. Statistical Methods in Medical Research, 3, 345-381.
-
(1994)
Statistical Methods in Medical Research
, vol.3
, pp. 345-381
-
-
Tudor, G.1
Koch, G.2
-
436
-
-
0030884090
-
A practical approach for the assessment of bioequivalence under selected higher order cross-over designs
-
Vuorinen, J. (1997) A practical approach for the assessment of bioequivalence under selected higher order cross-over designs. Statistics in Medicine, 16, 2229-2243.
-
(1997)
Statistics in Medicine
, vol.16
, pp. 2229-2243
-
-
Vuorinen, J.1
-
437
-
-
0030461283
-
A three step procedure for assessing bioequivalence in the general mixed linear framework
-
Vuorinen, J., Turunen, J. (1996) A three step procedure for assessing bioequivalence in the general mixed linear framework. Statistics in Medicine, 15, 2635-2655.
-
(1996)
Statistics in Medicine
, vol.15
, pp. 2635-2655
-
-
Vuorinen, J.1
Turunen, J.2
-
438
-
-
4243839021
-
Bayesian analysis of linear and non-linear population models by using the Gibbs sampler
-
Wakefield, J.C., Smith, A.F.-M., Racine-Poon, A., Gelfand, A.E. (1994) Bayesian analysis of linear and non-linear population models by using the Gibbs sampler. Applied Statistics, 43, 201-221.
-
(1994)
Applied Statistics
, vol.43
, pp. 201-221
-
-
Wakefield, J.C.1
Smith, A.F.-M.2
Racine-Poon, A.3
Gelfand, A.E.4
-
439
-
-
0003625523
-
-
Prentice Hall, New Jersey
-
Walpole, R.E., Myers, R.H., Myers, S.L. (1998) Probability and Statistics for Engineers and Scientists, 6ed. Prentice Hall, New Jersey.
-
(1998)
Probability and Statistics for Engineers and Scientists, 6ed.
-
-
Walpole, R.E.1
Myers, R.H.2
Myers, S.L.3
-
440
-
-
0025140843
-
On the lower bound of confidence coefficients for a confidence interval on variance components
-
Wang, C.M. (1990) On the lower bound of confidence coefficients for a confidence interval on variance components. Biometrics, 46, 187-192.
-
(1990)
Biometrics
, vol.46
, pp. 187-192
-
-
Wang, C.M.1
-
441
-
-
70249149495
-
Optimal unbiased tests for equivalence in intrasubject variability
-
Wang, W. (1997) Optimal unbiased tests for equivalence in intrasubject variability. Journal of the American Statistical Association, 88, 939-946.
-
(1997)
Journal of the American Statistical Association
, vol.88
, pp. 939-946
-
-
Wang, W.1
-
443
-
-
0033120492
-
Use of jacknife influence profiles in bioequivalence evaluations
-
Wang, Y. (1999) Use of jacknife influence profiles in bioequivalence evaluations. Pharmaceutical Science and Technology Today, 2, 152-159.
-
(1999)
Pharmaceutical Science and Technology Today
, vol.2
, pp. 152-159
-
-
Wang, Y.1
-
444
-
-
84985644178
-
Basing the analysis of comparative bioavailability trials on an individualized statistical definition of equivalence
-
Welleck, S. (1993) Basing the analysis of comparative bioavailability trials on an individualized statistical definition of equivalence. Biometrical Journal, 35, 47-55.
-
(1993)
Biometrical Journal
, vol.35
, pp. 47-55
-
-
Welleck, S.1
-
445
-
-
0030975585
-
A comment on so called individual criteria of bioequivalence
-
Welleck, S. (1997) A comment on so called individual criteria of bioequivalence. Journal of Biopharmaceutical Statistics, 7, 17-21.
-
(1997)
Journal of Biopharmaceutical Statistics
, vol.7
, pp. 17-21
-
-
Welleck, S.1
-
446
-
-
0034735534
-
On a reasonable disaggregate criterion of population bioequivalence admitting of resampling-free testing procedures
-
Welleck, S. (2000) On a reasonable disaggregate criterion of population bioequivalence admitting of resampling-free testing procedures. Statistics in Medicine, 19, 2755-2767.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2755-2767
-
-
Welleck, S.1
-
448
-
-
0026655012
-
Loss of seizure control associated with generic substitution of carbamazepine
-
Welty, T.E., Pickering, P.R., Hale, B.C., Arazi, R. (1992) Loss of seizure control associated with generic substitution of carbamazepine. Annals of Pharmacotherapy, 26, 775-777.
-
(1992)
Annals of Pharmacotherapy
, vol.26
, pp. 775-777
-
-
Welty, T.E.1
Pickering, P.R.2
Hale, B.C.3
Arazi, R.4
-
449
-
-
0031482736
-
Multiple testing of general contrasts using logical constraints and correlations
-
Westfall, P. (1997) Multiple testing of general contrasts using logical constraints and correlations. Journal of the American Statistical Association, 92, 299-306.
-
(1997)
Journal of the American Statistical Association
, vol.92
, pp. 299-306
-
-
Westfall, P.1
-
450
-
-
0003610576
-
-
SAS Institute, Cary, NC
-
Westfall, P., Tobias, R., Rom, D., Wolfinger, R., Hochberg, Y. (1999) Multiple Comparisons and Multiple Tests using SAS. SAS Institute, Cary, NC.
-
(1999)
Multiple Comparisons and Multiple Tests using SAS
-
-
Westfall, P.1
Tobias, R.2
Rom, D.3
Wolfinger, R.4
Hochberg, Y.5
-
451
-
-
0015379868
-
Use of confidence intervals in analysis of comparative bioavailability trials
-
Westlake, W.J. (1972) Use of confidence intervals in analysis of comparative bioavailability trials. Journal of Pharmaceutical Sciences, 61, 1340-1341.
-
(1972)
Journal of Pharmaceutical Sciences
, vol.61
, pp. 1340-1341
-
-
Westlake, W.J.1
-
452
-
-
0018411703
-
Statistical aspects of comparative bioavilability trials
-
Westlake, W.J. (1979) Statistical aspects of comparative bioavilability trials. Biometrics, 35, 273-280.
-
(1979)
Biometrics
, vol.35
, pp. 273-280
-
-
Westlake, W.J.1
-
453
-
-
0000470568
-
Bioavailability and bioequivalence of pharmaceutical formulations
-
Peace, K. ed, Marcel Dekker, New York
-
Westlake, W.J. (1986) Bioavailability and bioequivalence of pharmaceutical formulations. In Biopharmaceutical Statistics for Drug Development, Peace, K. ed., 329-352. Marcel Dekker, New York.
-
(1986)
Biopharmaceutical Statistics for Drug Development
, pp. 329-352
-
-
Westlake, W.J.1
-
455
-
-
0030463879
-
Sequential designs for equivalence studies
-
Whitehead, J. (1996) Sequential designs for equivalence studies. Statistics in Medicine, 15, 2703-2715.
-
(1996)
Statistics in Medicine
, vol.15
, pp. 2703-2715
-
-
Whitehead, J.1
-
456
-
-
0034832384
-
Learning from previous responses in phase 1 dose escalation studies
-
Whitehead, J., Zhou, Y., Stallard, N., Todd, S., Whitehead, A. (2001) Learning from previous responses in phase 1 dose escalation studies. British Journal of Clinical Pharmacology, 52, 1-7.
-
(2001)
British Journal of Clinical Pharmacology
, vol.52
, pp. 1-7
-
-
Whitehead, J.1
Zhou, Y.2
Stallard, N.3
Todd, S.4
Whitehead, A.5
-
458
-
-
0033810572
-
Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence?
-
and FDA Biopharmaceutics Coordinating Committee
-
Williams, R.L., Adams, W., Chen, M.-L., Hare, D., Hussain, A., Lesko, L., Patnaik, R., Shah, V., and FDA Biopharmaceutics Coordinating Committee (2000a) Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? European Journal of Drug Metabolism and Pharmacokinetics, 25, 7-12.
-
(2000)
European Journal of Drug Metabolism and Pharmacokinetics
, vol.25
, pp. 7-12
-
-
Williams, R.L.1
Adams, W.2
Chen, M.-L.3
Hare, D.4
Hussain, A.5
Lesko, L.6
Patnaik, R.7
Shah, V.8
-
459
-
-
0033820341
-
The basis for individual bioequivalence
-
Williams, R.L., Patnaik, R.N., Chen, M.-L. (2000b) The basis for individual bioequivalence. European Journal of Drug Metabolism and Pharmacokinetics, 25, 13-17.
-
(2000)
European Journal of Drug Metabolism and Pharmacokinetics
, vol.25
, pp. 13-17
-
-
Williams, R.L.1
Patnaik, R.N.2
Chen, M.-L.3
-
460
-
-
0001194565
-
Computing gaussian likelihoods and their derivatives for general linear mixed models
-
Wolfinger, R., Tobias, R., Sall, J. (1994) Computing gaussian likelihoods and their derivatives for general linear mixed models. Siam J Sci Comput, 15, 1294-1310.
-
(1994)
Siam J Sci Comput
, vol.15
, pp. 1294-1310
-
-
Wolfinger, R.1
Tobias, R.2
Sall, J.3
-
461
-
-
0033862457
-
Nonconjugate Bayesian analysis of variance component models
-
Wolfinger, R.D., Kass, R.E. (2000) Nonconjugate Bayesian analysis of variance component models. Biometrics, 56, 768-774.
-
(2000)
Biometrics
, vol.56
, pp. 768-774
-
-
Wolfinger, R.D.1
Kass, R.E.2
-
462
-
-
0034967764
-
Postmarketing reports of QT prolongation and ventricular arrhythmia in association with Cisapride and FDA regulatory actions
-
Wysowski, D., Corken, A., Gallo-Torres, H., Talarico, L., Rodriguez, E. (2001) Postmarketing reports of QT prolongation and ventricular arrhythmia in association with Cisapride and FDA regulatory actions. American Journal of Gastroenterology, 96, 1698-1703.
-
(2001)
American Journal of Gastroenterology
, vol.96
, pp. 1698-1703
-
-
Wysowski, D.1
Corken, A.2
Gallo-Torres, H.3
Talarico, L.4
Rodriguez, E.5
-
463
-
-
0033668377
-
Who needs individual bioequivalence studies for narrow therapeutic index drugs? A case for warfarin
-
Yacobi, A., Masson, E., Moros, D., Ganes, D., Lapointe, C., Abolfathi, Z., LeBel, M., Golander, Y., Doepner, D., Blumberg, T., Cohen, Y., Levitt, B. (2000) Who needs individual bioequivalence studies for narrow therapeutic index drugs? A case for warfarin. Journal of Clinical Pharmacology, 40, 826-835.
-
(2000)
Journal of Clinical Pharmacology
, vol.40
, pp. 826-835
-
-
Yacobi, A.1
Masson, E.2
Moros, D.3
Ganes, D.4
Lapointe, C.5
Abolfathi, Z.6
LeBel, M.7
Golander, Y.8
Doepner, D.9
Blumberg, T.10
Cohen, Y.11
Levitt, B.12
-
464
-
-
77952581126
-
Which is more important in pharmacokinetics:Inter-ethnic variability or intra-ethnic variability
-
D’Arcy, PF., Harron, D., eds
-
Yasuhara, H. (1994) Which is more important in pharmacokinetics:inter-ethnic variability or intra-ethnic variability. In Proceedings of the Second International Conference on Harmonisation, 1993, D’Arcy, PF., Harron, D., eds.
-
(1994)
Proceedings of the Second International Conference on Harmonisation, 1993
-
-
Yasuhara, H.1
-
465
-
-
0018111355
-
Statistical moments in pharmacokinetics
-
Yamaoka, K., Nakagawa, T., Uno, T. (1978) Statistical moments in pharmacokinetics. Journal of Pharmacokinetics and Biopharmaceutics, 6, 547-558.
-
(1978)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.6
, pp. 547-558
-
-
Yamaoka, K.1
Nakagawa, T.2
Uno, T.3
-
466
-
-
0023021373
-
The calculation of probabilities in rejecting bioequivalence
-
Yee, K.F. (1986) The calculation of probabilities in rejecting bioequivalence. Biometrics, 42, 961-965.
-
(1986)
Biometrics
, vol.42
, pp. 961-965
-
-
Yee, K.F.1
-
467
-
-
0017884783
-
A comparison of numerical integrating algorithms of trapezoidal, Legrange, and spline approximation
-
Yeh, K.C., Kwan, K.C. (1978) A comparison of numerical integrating algorithms of trapezoidal, Legrange, and spline approximation. Journal of Pharmacokinetics and Biopharmaceutics, 6, 79-81.
-
(1978)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.6
, pp. 79-81
-
-
Yeh, K.C.1
Kwan, K.C.2
-
468
-
-
0028453062
-
Population pharmacokinetic-pharmacodynamic methodology and applications:A bibliography
-
Yuh, L., Beal, S., Davidian, M., Harrison, F., Hester, A., Kowalski, K., Vonesh, E., Wolfinger, R. (1994) Population pharmacokinetic-pharmacodynamic methodology and applications:A bibliography. Biometrics, 50, 566-575.
-
(1994)
Biometrics
, vol.50
, pp. 566-575
-
-
Yuh, L.1
Beal, S.2
Davidian, M.3
Harrison, F.4
Hester, A.5
Kowalski, K.6
Vonesh, E.7
Wolfinger, R.8
-
469
-
-
85052765015
-
Case Studies, comparison of the current and proposed bioequivalence criteria
-
Zariffa, N., M.-D., Patterson, S.D., Boyle, D., Hyneck, H. (1998) Case Studies, comparison of the current and proposed bioequivalence criteria. FDA/AAPS Workshop on Bioavailability and Bioequivalence.
-
(1998)
FDA/AAPS Workshop on Bioavailability and Bioequivalence
-
-
Zariffa, N.M.-D.1
Patterson, S.D.2
Boyle, D.3
Hyneck, H.4
-
472
-
-
0034735560
-
Case studies, practical issues, and observations on population and individual bioequivalence
-
Zariffa, N., M.-D., Patterson, S.D., Boyle, D., Hyneck, H. (2000) Case studies, practical issues, and observations on population and individual bioequivalence. Statistics in Medicine, 19, 2811-2820.
-
(2000)
Statistics in Medicine
, vol.19
, pp. 2811-2820
-
-
Zariffa, N.M.-D.1
Patterson, S.D.2
Boyle, D.3
Hyneck, H.4
-
473
-
-
0034921142
-
Population and individual bioequivalence: Lessons from real data and simulation studies
-
Zariffa, N.M-D., Patterson, S.D. (2001) Population and individual bioequivalence: Lessons from real data and simulation studies. Journal of Clinical Pharmacology, 41, 811-822.
-
(2001)
Journal of Clinical Pharmacology
, vol.41
, pp. 811-822
-
-
Zariffa, N.M.-D.1
Patterson, S.D.2
|