-
2
-
-
0033369822
-
Bioequivalence studies: Biometrical concepts of alternative designs and pooled analysis
-
Zintzaras E. and Bouka P. (1999): Bioequivalence studies: biometrical concepts of alternative designs and pooled analysis. Eur J Drug Metab Pharmacokinet, 24, 225-232.
-
(1999)
Eur J Drug Metab Pharmacokinet
, vol.24
, pp. 225-232
-
-
Zintzaras, E.1
Bouka, P.2
-
7
-
-
0034439279
-
The existence of sequence effect in cross-over Bioequivalence trials
-
Zintzaras E (2000): The existence of sequence effect in cross-over Bioequivalence trials. Eur. J Drug Metab Pharmacokinet, 25, 241-244.
-
(2000)
Eur J Drug Metab Pharmacokinet
, vol.25
, pp. 241-244
-
-
Zintzaras, E.1
-
8
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability
-
Shuirmann D.J. (1987): 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)
J Pharmacokinet Biopharm
, vol.15
, pp. 657-680
-
-
Shuirmann, D.J.1
-
9
-
-
0025332058
-
A distribution-free procedure for the statistical analysis of bioequivalence studies
-
Hauschke D. (1990): A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharm Ther Toxic, 28, 72-78.
-
(1990)
Int J Clin Pharm Ther Toxic
, vol.28
, pp. 72-78
-
-
Hauschke, D.1
-
12
-
-
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
-
13
-
-
0031721971
-
Individual bioequivalence: Attractive in principle, difficult in practice
-
Endrenyi L, Amidon G.L., Midha K.K. Skelly JP. (1998): Individual bioequivalence: attractive in principle, difficult in practice. Pharm Res, 15, 1321-1325
-
(1998)
Pharm Res
, vol.15
, pp. 1321-1325
-
-
Endrenyi, L.1
Amidon, G.L.2
Midha, K.K.3
Skelly, J.P.4
-
14
-
-
0030011261
-
Towards a practical strategy for assessing individual bioequivalence
-
Schall R. and Williams R.L. (1996) Towards a practical strategy for assessing individual bioequivalence. J Pharmacok Biopharm, 24, 133-152.
-
(1996)
J Pharmacok Biopharm
, vol.24
, pp. 133-152
-
-
Schall, R.1
Williams, R.L.2
-
15
-
-
0031779119
-
In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2
-
Shah VP, Tsong Y, Sathe P, Liu JP (1998) In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2. Pharm Res. 15, 889-896.
-
(1998)
Pharm Res
, vol.15
, pp. 889-896
-
-
Shah, V.P.1
Tsong, Y.2
Sathe, P.3
Liu, J.P.4
-
16
-
-
0036203829
-
Biometrical evaluation of bioequivalence trials using a bootstrap individual direct curve comparison method
-
Zintzaras E. Bouka P. and A. Kowald (2002): Biometrical evaluation of bioequivalence trials using a bootstrap individual direct curve comparison method. Eur J Drug Metab Pharmacokinet, 27, 11-16.
-
(2002)
Eur J Drug Metab Pharmacokinet
, vol.27
, pp. 11-16
-
-
Zintzaras, E.1
Bouka, P.2
Kowald, A.3
-
19
-
-
0025958371
-
Sample size determination for bioequivalencce assessment by means of confidence intervals
-
Diletti E. et al. (1991): Sample size determination for bioequivalencce assessment by means of confidence intervals. Int J Clin Pharm Ther Toxic, 29, 1-8.
-
(1991)
Int J Clin Pharm Ther Toxic
, vol.29
, pp. 1-8
-
-
Diletti, E.1
-
20
-
-
0026772726
-
Bioequivalence
-
Rescigno A. (1992): Bioequivalence. Pharm. Res., 9, 925-928.
-
(1992)
Pharm Res
, vol.9
, pp. 925-928
-
-
Rescigno, A.1
-
21
-
-
0026597801
-
Types of Bioequivalence and related statistical considerations
-
Hauck W.W. and Anderson S. (1992): Types of Bioequivalence and related statistical considerations. Int J Clin Pharmacol Ther Toxicol, 30, 181-187.
-
(1992)
Int J Clin Pharmacol Ther Toxicol
, vol.30
, pp. 181-187
-
-
Hauck, W.W.1
Anderson, S.2
-
23
-
-
0034735563
-
An Individual Bioequivalence Criterion: Regulatory considerations
-
Chen ML. Patnaik R, Hauck WW, Shuirmann DJ, Hyslop T, William R. (2000): An Individual Bioequivalence Criterion: regulatory considerations. Stat Med, 19, 2821-2842.
-
(2000)
Stat Med
, vol.19
, pp. 2821-2842
-
-
Chen, M.L.1
Patnaik, R.2
Hauck, W.W.3
Shuirmann, D.J.4
Hyslop, T.5
William, R.6
-
24
-
-
0034123537
-
-
Hauck W.W, Hyslop T, Chen ML, Patnaik R, William R. (2000): Subject-by-Formulation Interaction in Bioequivalence: Conseptual and Statistical Issues Pharm Research, 17, 375-380.
-
(2000)
Subject-by-Formulation Interaction in Bioequivalence: Conseptual and Statistical Issues Pharm Research
, vol.17
, pp. 375-380
-
-
Hauck, W.W.1
Hyslop, T.2
Chen, M.L.3
Patnaik, R.4
William, R.5
|