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# ICH Bioquivalence Guidance Out
- URL: https://www.fdaweb.com/ich-bioquivalence-guidance-out/
- Published: 2024-10-30T12:00:00.000Z
- Updated: 2026-09-14T14:45:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158082

FDA has published the International Council for Harmonization’s M13A guidance, *Bioequivalence for Immediate-Release Solid Oral Dosage Forms*, with recommendations on conducting bioequivalence studies during both development and post-approval phases for orally administered immediate-release solid dosage forms designed to deliver drugs to the systemic circulation. The [document](ttps://www.fda.gov/media/165049/download) says deviations from its recommendations may be acceptable if appropriate scientific justification is provided.

The guidance contains an Introduction, General Principles in Establishing Bioequivalence, Specific Topics, Documentation, and a Glossary.