FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence

FDA has published a draft guidance on Dec. 5, 2022, with recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drug applications, new drug applications, abbreviated new drug applications, and supplements to these applications.

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. After being finalized, it will replace the Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, which was originally issued in February 2001.

In addition to covering some of the topics in the 2001 guidance, subjects discussed in the new guidance will include missing data, intercurrent events, narrow therapeutic index drugs, variable drugs, and data preparation.

The draft guidance can be viewed in full here.

Source: FDA