U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms October 2024

Download the Final Guidance Document
Final
Docket Number:
FDA-2023-D-0093
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.

Questions and Answers

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-0093.

Back to Top