Food and Drug Administration

Advisory Committee for Pharmaceutical Science

May 7-8, 2002

Briefing Information

Table of Contents htm   doc  pdf

May 7, 2002

Background: Food Effect Bioavailability (BA) and Bioequivalence (BE) Studies, April 10, 2002   pdf   htm   doc

Guidance For Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies: Study Design, Data Analysis, and Labeling  pdf

Guidance For Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies pdf

Biopharmaceutics Classification System (BCS): A Regulatory Risk Management Tool, Ajaz Hussain, PhD, FDA pdf

Bibliography  htm  doc  pdf