-
1
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
-
D. J. Schuirmann, A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15(6)):657-680 (1987).
-
(1987)
J Pharmacokinet Biopharm
, vol.15
, Issue.6
, pp. 657-680
-
-
Schuirmann, D.J.1
-
2
-
-
0009536863
-
Interim Guidance for Documentation of in Vivo Bioequivalence of Albuterol Inhalation Aerosols (Metered Dose Inhalers)
-
Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, January 27
-
Interim Guidance for Documentation of in Vivo Bioequivalence of Albuterol Inhalation Aerosols (Metered Dose Inhalers). Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA, January 27, 1994.
-
(1994)
-
-
-
3
-
-
0025228054
-
Application of the NONMEM method to evaluation of the bioavailability of drug products
-
N. Kaniwa, N. Aoyagi, H. Ogata, and M. Ishii, Application of the NONMEM method to evaluation of the bioavailability of drug products. J Pharm Sci 79(12)):1116-1120 (1990).
-
(1990)
J Pharm Sci
, vol.79
, Issue.12
, pp. 1116-1120
-
-
Kaniwa, N.1
Aoyagi, N.2
Ogata, H.3
Ishii, M.4
-
4
-
-
0033379345
-
Characterization of the highly variable bioavailability of tiludronate in normal volunteers using population pharmacokinetic methodologies
-
G. A. Maier, G. G. Lockwood, J. A. Oppermann, et al., Characterization of the highly variable bioavailability of tiludronate in normal volunteers using population pharmacokinetic methodologies. Eur J Drug Metab Pharmacokinet 24(3)):249-254 (1999).
-
(1999)
Eur J Drug Metab Pharmacokinet
, vol.24
, Issue.3
, pp. 249-254
-
-
Maier, G.A.1
Lockwood, G.G.2
Oppermann, J.A.3
-
5
-
-
0029764187
-
Bioequivalence: individual and population compartmental modeling compared to the noncompartmental approach
-
H. S. Pentikis, J. D. Henderson, N. L. Tran, and T. M. Ludden, Bioequivalence: individual and population compartmental modeling compared to the noncompartmental approach. Pharm Res 13(7)):1116-1121 (1996).
-
(1996)
Pharm Res
, vol.13
, Issue.7
, pp. 1116-1121
-
-
Pentikis, H.S.1
Henderson, J.D.2
Tran, N.L.3
Ludden, T.M.4
-
6
-
-
0034986874
-
Population pharmacokinetic modeling of steady state carbamazepine clearance in children, adolescents, and adults
-
D. M. Reith, W. D. Hooper, J. Parke, and B. Charles, Population pharmacokinetic modeling of steady state carbamazepine clearance in children, adolescents, and adults. J Pharmacokinet Biopharm 28(1)):79-92 (2001).
-
(2001)
J Pharmacokinet Biopharm
, vol.28
, Issue.1
, pp. 79-92
-
-
Reith, D.M.1
Hooper, W.D.2
Parke, J.3
Charles, B.4
-
7
-
-
0003884301
-
Statistical Issues in Drug Development
-
Wiley, Hoboken, NJ
-
S. Senn, Statistical Issues in Drug Development. Wiley, Hoboken, NJ, 1997.
-
(1997)
-
-
Senn, S.1
-
8
-
-
0000039381
-
On the cost of data analysis
-
J. J. Faraway, On the cost of data analysis. J Comput Graphical Stat 1:213-229 (1992).
-
(1992)
J Comput Graphical Stat
, vol.1
, pp. 213-229
-
-
Faraway, J.J.1
-
9
-
-
0036378736
-
Report of a workshop on confirmatory evidence to support a single clinical trial as a basis for new drug approval
-
C. C. Peck and J. Wechsler, Report of a workshop on confirmatory evidence to support a single clinical trial as a basis for new drug approval. Drug Inf J 36:517-534 (2002).
-
(2002)
Drug Inf J
, vol.36
, pp. 517-534
-
-
Peck, C.C.1
Wechsler, J.2
-
10
-
-
0003991665
-
An Introduction to the Bootstrap
-
Chapman & Hall, New York
-
B. Efron and R. J. Tibshirani, An Introduction to the Bootstrap. Chapman & Hall, New York, 1993.
-
(1993)
-
-
Efron, B.1
Tibshirani, R.J.2
-
11
-
-
0003732572
-
Regression Modeling Strategies: With Applications to Linear Models, Logistic Regression, and Survival Analysis
-
Springer-Verlag, New York
-
F. Harrell, Regression Modeling Strategies: With Applications to Linear Models, Logistic Regression, and Survival Analysis. Springer-Verlag, New York, 2001.
-
(2001)
-
-
Harrell, F.1
-
12
-
-
0030953226
-
Stability and performance of a population pharmacokinetic model
-
E. I. Ette, Stability and performance of a population pharmacokinetic model. J Clin Pharmacol 37:486-495 (1997).
-
(1997)
J Clin Pharmacol
, vol.37
, pp. 486-495
-
-
Ette, E.I.1
-
13
-
-
0003860037
-
Markov Chain Monte Carlo in Practice
-
Chapman & Hall, London
-
W. R. Gilks, S. Richardson, and D. J. Spiegelhalter, Markov Chain Monte Carlo in Practice. Chapman & Hall, London, 1996.
-
(1996)
-
-
Gilks, W.R.1
Richardson, S.2
Spiegelhalter, D.J.3
-
14
-
-
0038243538
-
Model appropriateness and population pharmacokinetic modeling
-
E. Ette, P. J. Williams, Y. H. Kim, J. R. Lane, M. Liu, and E. V. Capparelli, Model appropriateness and population pharmacokinetic modeling. J Clin Pharmacol 43:610-623 (2003).
-
(2003)
J Clin Pharmacol
, vol.43
, pp. 610-623
-
-
Ette, E.1
Williams, P.J.2
Kim, Y.H.3
Lane, J.R.4
Liu, M.5
Capparelli, E.V.6
-
15
-
-
0031460242
-
Influence of race or ethnicity on pharmacokinetics of drugs
-
J. A. Johnson, Influence of race or ethnicity on pharmacokinetics of drugs. J Pharm Sci 86:1328-1333 (1997).
-
(1997)
J Pharm Sci
, vol.86
, pp. 1328-1333
-
-
Johnson, J.A.1
-
16
-
-
0035115820
-
In vivo effect of alpha-1-acid glycoprotein on pharmacokinetics of amprenavir, a human immunodeficiency virus protease inhibitor
-
B. M. Sadler, C. Gillotin, Y. Lou, and D. S. Stein, In vivo effect of alpha-1-acid glycoprotein on pharmacokinetics of amprenavir, a human immunodeficiency virus protease inhibitor. Antimicrob Agents Chemother 45:852-856 (2001).
-
(2001)
Antimicrob Agents Chemother
, vol.45
, pp. 852-856
-
-
Sadler, B.M.1
Gillotin, C.2
Lou, Y.3
Stein, D.S.4
-
17
-
-
0003747347
-
NONMEM User's Guide
-
NONMEM Project Group, UCSF
-
S. L. Beal and L. B. Sheiner, NONMEM User's Guide. NONMEM Project Group, UCSF, 1992.
-
(1992)
-
-
Beal, S.L.1
Sheiner, L.B.2
-
18
-
-
0036859678
-
A methacholine challenge dose-response study for development of a pharmacodynamic bioequivalence methodology for albuterol metered-dose inhalers
-
P. Creticos, W. Adams, B. Petty, L. Lewis, and G. Singh, A methacholine challenge dose-response study for development of a pharmacodynamic bioequivalence methodology for albuterol metered-dose inhalers. J Allergy Clin Immunol 110:713-720 (2002).
-
(2002)
J Allergy Clin Immunol
, vol.110
, pp. 713-720
-
-
Creticos, P.1
Adams, W.2
Petty, B.3
Lewis, L.4
Singh, G.5
-
19
-
-
0036065168
-
Assessment of comparative bioequivalence of two metered-dose inhaler formulations of salbutamol-measuring bronchodilatory effect in patients with asthma
-
H. Leon-Molina, F. Flores-Murrieta, and R. Chapela, Assessment of comparative bioequivalence of two metered-dose inhaler formulations of salbutamol-measuring bronchodilatory effect in patients with asthma. Clin Drug Invest 22(7)):435-441 (2002).
-
(2002)
Clin Drug Invest
, vol.22
, Issue.7
, pp. 435-441
-
-
Leon-Molina, H.1
Flores-Murrieta, F.2
Chapela, R.3
-
20
-
-
0033437147
-
Concepts of establishing clinical bioequivalence of chlorofluorocarbon and hydrofluoroalkane b-agonists
-
K. Parameswaran, Concepts of establishing clinical bioequivalence of chlorofluorocarbon and hydrofluoroalkane b-agonists. J Allergy Clin Immunol 104(6):S243-S245 (1999).
-
(1999)
J Allergy Clin Immunol
, vol.104
, Issue.6
-
-
Parameswaran, K.1
-
21
-
-
0032698154
-
Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling
-
G. Singh, W. Adams, L. Lesko, et al., Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling. Clin Pharmacol Ther 66(4)):346-357 (1999).
-
(1999)
Clin Pharmacol Ther
, vol.66
, Issue.4
, pp. 346-357
-
-
Singh, G.1
Adams, W.2
Lesko, L.3
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