Individual Bioequivalence Tests under 3 X 2 Design

Title & Authors
Individual Bioequivalence Tests under 3 X 2 Design
Jung, Gyu-Jin; Lim, Nam-Kyoo; Park, Sang-Gue;

Abstract
In recent years, more generic drug products became available. The current regulation for assessing the bioequivalence of two drug formulations is based on the concept of average bioequivalence. This approach has been indicated to be insufficient for assessing switchability between two drug formulations and US FDA has adopted individual bioequivalence as one of the bioequivalence criterion since 2001. The US FDA recommends that individual bioequivalence be assessed based on $\small{2\;{\times}\;4}$ crossover design, while a $\small{2\;{\times}\;3}$ crossover design may be used as an alternative design to reduce the length and cost of the study. In this paper, a statistical procedure for assessment of individual bioequivalence under $\small{3\;{\times}\;2}$ crossover designs is proposed and some statistical points are discussed with $\small{2\;{\times}\;3}$ crossover design and $\small{2\;{\times}\;3}$ extra-reference design through simulation studies.
Keywords
Cross-over design;extra-reference design;individual bioequivalence;
Language
Korean
Cited by
1.
변이가 큰 약물의 생물학적 동등성 평가에 관한 연구,정규진;박상규;

응용통계연구, 2011. vol.24. 6, pp.1055-1076
2.
Bayesian Estimation in Bioequivalence Study,;

응용통계연구, 2011. vol.24. 6, pp.1095-1102
1.
Bayesian Estimation in Bioequivalence Study, Korean Journal of Applied Statistics, 2011, 24, 6, 1095
2.
On Evaluation of Bioequivalence for Highly Variable Drugs, Korean Journal of Applied Statistics, 2011, 24, 6, 1055
References
1.
Anderson, S. and Hauck, W. W. (1990). Consideration of individual bioequivalence, Journal of Pharmacokinetics and Pharmacodynamics, 18, 259-273.

2.
Chow, S. C., Shao, J. and Wang, H. (2002). Individual bioequivalence testing under 2 ${\times}$ 3 designs, Statistics in Medicine, 21, 629-648.

3.
Esinhart, J. D. and Chinchilli, V. M. (1994). Extension to the use of tolerance intervals for the assessment of individual bioequivalence, Journal of Biopharmaceutical Statistics, 4, 39-52.

4.
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.

5.
Hyslop, T., Hsuan, F. and Holder, D. J. (2000). A small sample confidence interval approach to assess individual bioequivalence, Statistics in Medicine, 19, 2885-2897.

6.
Sheiner, L. B. (1992). Bioequivalence revisited, Statistics in Medicine, 11, 1777-1788.

7.
Schall, R. and Luus, H. G. (1993). On population and individual bioequivalence, Statistics in Medicine, 12, 1109-1124.

8.
US Food and Drug Administration (1992). Guidance on Statistical procedures for Bioequivalence using a standard two-treatment crossover design, Rockville, MD.

9.
US Food and Drug Administration (2001). Statistical Approaches to Establishing Bioequivalence, Rockville, MD.