Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies

摘要

This guidance provides recommendations to sponsors and/or applicants planning to conduct food-effect bioavailability (BA) and fed bioequivalence (BE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. This guidance applies to both immediate-release and modified-release drug products. The guidance addresses how to meet the BA and BE requirements in 21 CFR 320, 314.50 (d) (3), and 314.94 (a) (7) as they apply to oral dosage forms. This guidance provides recommendations for food-effect BA and fed BE study designs, data analysis, and product labeling. It also provides information on when food-effect BA and fed BE studies should be performed.