Food and Drug Administration
Advisory Committee for Pharmaceutical Science
May 7-8, 2002
Briefing Information
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