Requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements; the definitions of BA and BE; and the types of in vitro and in vivo studies that are appropriate to measure BA and establish BE are set forth in part 320 (21 CFR part 320). This guidance provides recommendations on how to meet provisions of part 320 for all drug products.
This guidance provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro BE studies for INDs, NDAs, ANDAs, and supplements to these applications. This guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.
When finalized, this guidance will replace the guidance for industry Statistical Approaches to Establishing Bioequivalence, which was issued in February 2001 (2001 guidance). This guidance provides recommendations on the topics covered in the 2001 guidance as well as recommendations on additional topics, including missing data and intercurrent events, adaptive design, and specific situations, such as narrow therapeutic index drugs and highly variable drugs.