USA – Statistical Approaches to Establishing Bioequivalence

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Statistical Approaches to Establishing Bioequivalence.” This guidance provides recommendations to sponsors and/or applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drug applications (IND’s), new drug applications (NDA’s), abbreviated new drug applications (ANDA’s) and supplements to these applications. The guidance discusses the use of average, population, and individual BE approaches to compare in vivo and in vitro bioavailability (BA) measures. (This guidance replaces the draft guidance that was issued in 1999 entitled “Average, Population, and Individual Approaches to Establishing Bioequivalence.”)…