27/28 June 2023
Heidelberg, Germany
The U.S. Food and Drug Administration (FDA) has published a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence". When finalized, the new document will replace the previous version, which was issued in February 2001.
The guidance provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for
The introduction states that the "guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations."
The 29-page document starts with an introduction, giving a general overview about the content of the new document and some background information on previous documents on this subject, in particular:
The following chapter on general considerations covers the following aspects:
After that, the following specific situations are described:
The document also contains three appendices on the following aspects:
The document can be downloaded on the FDA's website.
The document is being distributed for comment purposes only. Comments and suggestions regarding the new draft document should be submitted within 60 days after publication in the Federal Register (until 04 February 2023).