Food and Drug Administration

Advisory Committee for Pharmaceutical Science

November 29, 2001

Briefing Information


Guidance for Industry: Topical Dermatological Drug Product NDAs and ANDAs -- In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies, Draft Guidance, June 1998 [pdf version]

Synopsis - Determination of tretinoin bioequivalence in man by stratum corneum tape stripping, Tom Franz   [pdf version] [htm version] [Word version]

Executive Summary - Bioquivalence of three tretinoin gel, 0.025% products, Lynn Pershing   [pdf version] [htm version] [Word version]

CDER internal dermatopharmacokinetic study, Mamata Gokhale  [pdf version] [htm version] [Word version]

Individual Bioequivalence

Introduction to the issues [pdf version] [htm version] [Word version]

Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products -- General Considerations, October 2000  [pdf version] [htm version]

Subject-by-Formulation Interaction, Examples   [pdf version]

Bioequivalence Criteria, Research Program, Draft 2, November 1, 2001  [pdf version] [htm version] [Word version]