References
Schuirmann D.J. (1987): Comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm., 15, 657–680.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and research. (1999): Draft Guidance for Industry: Average, population and individual approaches to establishing bioequivalence. (Internet) http://www.fda.gov/cder/guidance/index/htm
Hauck W.W., Anderson S. (1992): Types of bioequivalence and related statistical considerations. Int. J. Clin. Pharmacol. Ther., 30:181–187.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and research. (1999): Draft Guidance for Industry: BA and BE studies for orally administered drug products — general consideration.
Levy G. (1996): Bioequivalence assessment: Irrationality within a rational science. In: Midha K., Nagai T. (eds) Bioavailability, Bioequivalence and Pharmacokinetic Studies, FIP BIO-International ’96, Tokyo, Business Center for Academic Societies Japan, 29–32.
Endrenyi L., Amidon G.L., Midha K.K., Skelly J.P. (1998): Individual bioequivalence: attractive in principle, difficult in practice. Pharm. Res., 15, 1321–1325.
Williams R.L. (1999): Average and individual BE criteria to compare BE measures — replicate and non-replicate data sets. Advisory Committee for Pharmaceutical Science Meeting. September 23–24, 1999, Rockville, MD, USA.
Meyer M.C., Straughn A.B., Jarvi E.J. et al. (2000): Bioequivalence of methylphenidate immediate-release tablets using a replicated study design. Pharm. Res. In press.
Barrett J.S., Batra V., Chow A. et al. (2000): PhRMA perspective on population and individual bioequivalence. J. Clin. Pharmacol., 40, 561–570.
Sheiner L.B. (1992): Bioequivalence revisited. Stat. Med., 11, 1777–1788.
Author information
Authors and Affiliations
Consortia
Additional information
The FDA Population and Individual Bioequivalence Working Group functions under the Biopharmaceutics Coordinating Committee in the Center for Drug Evaluation and Research at the US Food and Drug Administration. As of September 1999, the members of this working group were Mei-Ling Chen (Co-Chair), Rabindra Patnaik (Co-Chair), Dale Conner, Lawrence Lesko, Stella Machado, Donald Schuirmann, Roger L. Williams, Walter Hauck (consultant), and Terry Hyslop (consultant).
Rights and permissions
About this article
Cite this article
Williams, R.L., Patnaik, R.N., Chen, ML. et al. The basis for individual bioequivalence. Eur. J. Drug Metab. Pharmacokinet. 25, 13–17 (2000). https://doi.org/10.1007/BF03190050
Issue Date:
DOI: https://doi.org/10.1007/BF03190050