FDA GUIDANCE · FINALMay 29, 2026

Statistical Approaches to Establishing Bioequivalence

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Biopharmaceutics, Generic Drugs

Issue date

May 29, 2026

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