-
1
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability
-
1. D. J. Schuirmann. A comparison of the two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15:657-680 (1987).
-
(1987)
J. Pharmacokinet. Biopharm.
, vol.15
, pp. 657-680
-
-
Schuirmann, D.J.1
-
2
-
-
0024988106
-
Consideration of individual bioequivalence
-
2. S. Anderson and W. W. Hauck. Consideration of individual bioequivalence. J. Pharmacokinet. Biopharm. 18:259-273 (1990).
-
(1990)
J. Pharmacokinet. Biopharm.
, vol.18
, pp. 259-273
-
-
Anderson, S.1
Hauck, W.W.2
-
3
-
-
0026597801
-
Types of Bioequivalence and related statistical considerations
-
3. W. W. Hauck and S. Anderson. Types of Bioequivalence and related statistical considerations. Int. J. Clin. Pharmacol. Ther. Toxicol. 30:181-187 (1992).
-
(1992)
Int. J. Clin. Pharmacol. Ther. Toxicol.
, vol.30
, pp. 181-187
-
-
Hauck, W.W.1
Anderson, S.2
-
4
-
-
0030011261
-
Towards a practical strategy for assessing individual bioequivalence
-
4. R. Schall and R. L. Williams for the FDA Individual Bioequivalence Working Group. Towards a practical strategy for assessing individual bioequivalence. J. Pharmacokinet. Biopharm. 24:133-149 (1996).
-
(1996)
J. Pharmacokinet. Biopharm.
, vol.24
, pp. 133-149
-
-
Schall, R.1
Williams, R.L.2
-
5
-
-
0030771117
-
Individual bioequivalence: New concepts in the statistical assessment of bioequivalence metrics
-
5. R. N. Patnaik, L. J. Lesko, M.-L. Chen, R. L. Williams, and the FDA Individual Bioequivalence Working Group. Individual bioequivalence: New concepts in the statistical assessment of bioequivalence metrics. Clin. Pharmacokinet. 33:1-6 (1997).
-
(1997)
Clin. Pharmacokinet.
, vol.33
, pp. 1-6
-
-
Patnaik, R.N.1
Lesko, L.J.2
Chen, M.-L.3
Williams, R.L.4
-
6
-
-
0013690696
-
An individual bioequivalence criterion: Regulatory considerations
-
in press
-
6. M.-L. Chen, R. N. Patnaik, W. W. Hauck, D. J. Schuirmann, T. Hyslop, R. L. Williams, and the FDA Population/Individual Bioequivalence Working Group. An individual bioequivalence criterion: Regulatory considerations. Statist. Med. in press.
-
Statist. Med.
-
-
Chen, M.-L.1
Patnaik, R.N.2
Hauck, W.W.3
Schuirmann, D.J.4
Hyslop, T.5
Williams, R.L.6
-
9
-
-
0026481178
-
Bioequivalence revisited
-
9. L. B. Sheiner. Bioequivalence revisited. Statist Med 11:1777-1788 (1992).
-
(1992)
Statist Med
, vol.11
, pp. 1777-1788
-
-
Sheiner, L.B.1
-
10
-
-
0027244039
-
On population and individual bioequivalence
-
10. R. Schall and H. G. Luus. On population and individual bioequivalence. Statist. Med. 12:1109-1124 (1993).
-
(1993)
Statist. Med.
, vol.12
, pp. 1109-1124
-
-
Schall, R.1
Luus, H.G.2
-
11
-
-
0001474373
-
Moment-based criteria for determining bioequivalence
-
11. D. J. Holder and F. Hsuan. Moment-based criteria for determining bioequivalence. Biometrika 80:835-846 (1993).
-
(1993)
Biometrika
, vol.80
, pp. 835-846
-
-
Holder, D.J.1
Hsuan, F.2
-
12
-
-
0028106933
-
A method for the evaluation of individual bioequivalence
-
12. L. Endrenyi. A method for the evaluation of individual bioequivalence. Int. J. Clin. Pharmacol. Ther. Toxicol. 32:497-508 (1994).
-
(1994)
Int. J. Clin. Pharmacol. Ther. Toxicol.
, vol.32
, pp. 497-508
-
-
Endrenyi, L.1
-
13
-
-
0029965765
-
The assessment of individual and population bioequivalence
-
13. V. M. Chinchilli. The assessment of individual and population bioequivalence. J. Biopharm. Statist. 6:1-14 (1996).
-
(1996)
J. Biopharm. Statist.
, vol.6
, pp. 1-14
-
-
Chinchilli, V.M.1
-
15
-
-
0019492559
-
Statistical simulation study of new proposed uniformity requirement for bioequivalence studies
-
15. J. D. Haynes. Statistical simulation study of new proposed uniformity requirement for bioequivalence studies. J. Pharm. Sci. 70:673-675 (1981).
-
(1981)
J. Pharm. Sci.
, vol.70
, pp. 673-675
-
-
Haynes, J.D.1
-
16
-
-
0024947084
-
The subject-by-formulation interaction as a criterion for interchangeability of drugs
-
16. G. Ekbohm and H. Melander. The subject-by-formulation interaction as a criterion for interchangeability of drugs. Biometrics 45:1249-1254 (1989).
-
(1989)
Biometrics
, vol.45
, pp. 1249-1254
-
-
Ekbohm, G.1
Melander, H.2
-
17
-
-
0031721971
-
Individual bioequivalence: Attractive in principle, difficult in practice
-
17. L. Endrenyi, G. L. Amidon, K. K. Midha, and J. P. Skelly. Individual bioequivalence: Attractive in principle, difficult in practice. Pharm. Res. 15:1321-1325 (1998).
-
(1998)
Pharm. Res.
, vol.15
, pp. 1321-1325
-
-
Endrenyi, L.1
Amidon, G.L.2
Midha, K.K.3
Skelly, J.P.4
-
18
-
-
0033013237
-
Subject-by-formulation interaction in determinations of individual bioequivalence: Bias and prevalence
-
18. L. Endrenyi and L. Tothfalusi. Subject-by-formulation interaction in determinations of individual bioequivalence: Bias and prevalence. Pharm. Res. 16:186-188 (1999).
-
(1999)
Pharm. Res.
, vol.16
, pp. 186-188
-
-
Endrenyi, L.1
Tothfalusi, L.2
-
19
-
-
85017207983
-
Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence
-
in press
-
19. L. Endrenyi, N. Taback, and L. Tothfalusi. Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence. Statist. Med., in press.
-
Statist. Med.
-
-
Endrenyi, L.1
Taback, N.2
Tothfalusi, L.3
-
20
-
-
0033618144
-
Selection bias and treatment heterogeneity in clinical trials
-
20. N. T. Longford. Selection bias and treatment heterogeneity in clinical trials. Statist Med 18:1467-1474 (1999).
-
(1999)
Statist Med
, vol.18
, pp. 1467-1474
-
-
Longford, N.T.1
-
21
-
-
0027165833
-
Differences in serum concentration of and responses to generic verapamil in the elderly
-
21. B. L. Carter, M. A. Noyes, and R. W. Demmler. Differences in serum concentration of and responses to generic verapamil in the elderly. Pharmacotherapy 13:359-368 (1993).
-
(1993)
Pharmacotherapy
, vol.13
, pp. 359-368
-
-
Carter, B.L.1
Noyes, M.A.2
Demmler, R.W.3
-
22
-
-
0013695185
-
Gender analysis of bioequivalence trials. American Society for Clinical Pharmacology and Therapeutics
-
New Orleans, Louisiana, March 30-April 1
-
22. M.-L. Chen, S.-C. Lee, M.-J. Ng, and D. J. Schuirmann. Gender analysis of bioequivalence trials. American Society for Clinical Pharmacology and Therapeutics, Ninety-ninth Annual Meeting, New Orleans, Louisiana, March 30-April 1, 1998.
-
(1998)
Ninety-ninth Annual Meeting
-
-
Chen, M.-L.1
Lee, S.-C.2
Ng, M.-J.3
Schuirmann, D.J.4
-
23
-
-
0029744834
-
Design and analysis of intra-subject variability in cross-over experiments
-
23. V. M. Chinchilli and J. D. Esinhart. Design and analysis of intra-subject variability in cross-over experiments. Statist. Med. 15:1619-1634 (1996).
-
(1996)
Statist. Med.
, vol.15
, pp. 1619-1634
-
-
Chinchilli, V.M.1
Esinhart, J.D.2
-
24
-
-
0029026110
-
Bioequivalence and narrow therapeutic index drugs
-
24. L. Z. Benet and J. E. Goyan. Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy 15:433-440 (1995).
-
(1995)
Pharmacotherapy
, vol.15
, pp. 433-440
-
-
Benet, L.Z.1
Goyan, J.E.2
-
25
-
-
0022477197
-
Confidence intervals for reporting results of clinical trials
-
25. R. Simon. Confidence intervals for reporting results of clinical trials. Ann. Intern. Med. 105:429-435 (1986).
-
(1986)
Ann. Intern. Med.
, vol.105
, pp. 429-435
-
-
Simon, R.1
-
26
-
-
0026030198
-
Confidence intervals assess both clinical significance and statistical significance
-
26. L. E. Braitman. Confidence intervals assess both clinical significance and statistical significance. Ann. Intern. Med. 114:515-517 (1991).
-
(1991)
Ann. Intern. Med.
, vol.114
, pp. 515-517
-
-
Braitman, L.E.1
-
27
-
-
0028304329
-
The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results
-
27. S. N. Goodman and J. A. Berlin. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann. Intern. Med. 121:200-206 (1994).
-
(1994)
Ann. Intern. Med.
, vol.121
, pp. 200-206
-
-
Goodman, S.N.1
Berlin, J.A.2
-
28
-
-
0021271539
-
A new statistical procedure for testing equivalence in two-group comparative bioavailability trials
-
28. W. W. Hauck and S. Anderson. A new statistical procedure for testing equivalence in two-group comparative bioavailability trials. J. Pharmacokinet. Biopharm. 12:83-91 (1984).
-
(1984)
J. Pharmacokinet. Biopharm.
, vol.12
, pp. 83-91
-
-
Hauck, W.W.1
Anderson, S.2
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