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Determination of in vivo bioequivalence
1Office of Generic Drugs, CDER, Division of Bioequivalence, FDA, Rockville, Maryland, USA. Jacksonan@CDER.FDA.Gov
Pharmaceutical Research
|April 6, 2002
Abstract:
The May and June 2001 issues of Pharmaceutical Research contained three articles related to the determination of in vivo Bioequivalence. The articles discussed: (a) the bioequivalence of highly variable drugs, (b) novel metrics for direct comparison of bioequivalence study plasma curves, and (c) the role of a microemulsion vehicle on cutaneous bioequivalence. An analysis of the relationship and potential impact of these articles on their respective areas of bioequivalence will be addressed in this commentary.