BRIEF—FDA draft guidance for establishing bioequivalence

The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, titled “ Statistical Approaches to Establishing Bioequivalence,” which provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications.

This guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches generally and in specific situations. The FDA intends the guidance to help applicants plan and analyze their BE studies with the goal of minimizing the number of assessment cycles necessary for approval.

When finalized, this guidance will replace the February 2001 FDA guidance for industry, and will represent the FDA’s current thinking on this topic.

The draft guidance provides recommendations on the topics covered in the February 2001 guidance as well as recommendations on additional topics, including: specific situations, such as narrow therapeutic index drugs and highly variable drugs; missing data and intercurrent events; an adaptive design.