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Determination of in Vivo Bioequivalence
Authors:Jackson  Andre J
Institution:(1) Office of Generic Drugs, CDER, Division of Bioequivalence, FDA, Rockville, Maryland
Abstract:The May and June 2001 issues of Pharmaceutical Research contained three articles related to the determination of in vivo Bioequivalence (1-3). 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 commentory.
Keywords:bioequivalence  highly-variable  metrics  cutaneous pharmacokinetics
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