Zdrowie i gospodarka · 28/11/2001

Draft Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies: Study Design, Data Analysis, and Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Food-Effect Bioavailability and Fed Bioequivalence Studies: Study Design, Data Analysis, and Labeling." The draft guidance is intended for sponsors planning to conduct food-effect bioavailability (BA) and fed bioequivalence (BE) studies for oral immediate-release and modified- release dosage forms as part of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. The draft guidance provides recommendations for study design, data analysis, and product labeling, and also indicates when food-effect BA and fed BE studies should be performed.