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# Draft Guide on Bioequivalence Statistical Approaches
- URL: https://www.fdaweb.com/draft-guide-on-bioequivalence-statistical-approaches/
- Published: 2022-12-02T12:00:00.000Z
- Updated: 2026-09-14T18:08:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153308

FDA has published a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-establishing-bioequivalence-0?ref=fdaweb.com) entitled “Statistical Approaches to Establishing Bioequivalence” that is intended to provide recommendations for submitting bioavailability and bioequivalence (BE) data in INDs, NDAs, ANDAs and related supplements. The document provides input for sponsors who intend to use equivalence criteria in analyzing *in vivo* or *in vitro* BE studies, and it discusses statistical approaches for BE comparisons, including how to use the approaches both generally and in specific situations.

When finalized, the guidance will replace the 2001 guidance under the same title. FDA says the revised guidance provides recommendations on the topics covered in the 2001 guidance, and covers additional topics, such as missing data and intercurrent events, adaptive designs, and narrow therapeutic index drugs and highly variable drugs.

“Given the evolving nature of statistical approaches and technologies, FDA encourages generic and new drug applicants to propose and discuss novel methodologies (e.g., model-based BE and novel adaptive designs for comparative clinical endpoint BE studies) with the agency through appropriate regulatory meeting,” the guidance says.