Determination of in Vivo Bioequivalence |
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Authors: | Jackson Andre J |
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Institution: | (1) Office of Generic Drugs, CDER, Division of Bioequivalence, FDA, Rockville, Maryland |
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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. |
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Keywords: | bioequivalence highly-variable metrics cutaneous pharmacokinetics |
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