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Dermatologic bioequivalence

This article was originally published in The Tan Sheet

Executive Summary

Bristol-Myers Squibb submits citizen petition to FDA Nov. 12 requesting the agency not finalize its draft guidance for industry - "Topical Dermatological Drug Product NDAs and ANDAs: In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies" - until FDA resolves certain outstanding issues. BMS suggests FDA's new dermatopharmacokinetics (DPK) method "has not been adequately tested" and the agency's proposed "standard of qualitative 'functional similarity' of inactive ingredients between test and reference products is broad and inappropriate." FDA issued the draft guidance in 1998 (1"The Tan Sheet" June 29, 1998, p. 25)

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