References
- Burdick, R. K., N. Thomas, and A. Cheng. 2017. Statistical considerations in demonstrating CMC analytical similarity for a biosimilar product. Statistics in Biopharmaceutical Research 9 (3):pages 249–257. doi:10.1080/19466315.2017.1280412.
- Chow, S.-C., J. Shao, and H. Wang. 2003. In vitro bioequivalence testing. Statistics in Medicine 22:55–68. doi:10.1002/(ISSN)1097-0258.
- Davit, B. M. et al. 2012. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration. AAPS Journal 14:915–924. doi:10.1208/s12248-012-9406-x.
- Dong, X., Y. Bian, Y. Tsong, and T. Wang. 2017. Exact test-based approach for equivalence test with parameter margin. Journal of Biopharmaceutical Statistics 27 (2):317–330. doi:10.1080/10543406.2016.1265546.
- Food and Drug Administration (FDA). 2001. Guidance for industry: Statistical approaches to establishing bioequivalence. U.S. Department of Health and Human Services, Washington, D.C.
- Food and Drug Administration (FDA). 2011. Draft guidance for industry: Bioequivalence recommendation for progesterone oral capsules. U.S. Department of Health and Human Services, Washington, D.C.
- Haidar, S. H. et al. 2007. Bioequivalence approaches for highly viable drugs and drug products. Pharmaceutical Research 25:237–241. doi:10.1007/s11095-007-9434-x.
- Haidar, S. H. et.al. 2008. Evaluation of scaling approach for the bioequivalence of highly variable drugs. The AAPS Journal 10:450–454. doi:10.1208/s12248-008-9053-4.
- 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 (347):789–794.
- Hyslop, T., F. Hsuan, and D. J. Holder. 2000. A small sample confidence interval approach to assess individual bioequivalence. Statistics in Medicine 19:2885–2897.
- Liao, J. J. Z., and J. F. Heyse. 2011. Biosimilarity for follow-on biologics. Statistics in Biopharmaceuticals Research 3 (3):445–455. doi:10.1198/sbr.2011.10036.