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# Guide on Bioequivalence Study Data Integrity
- URL: https://www.fdaweb.com/guide-on-bioequivalence-study-data-integrity/
- Published: 2024-04-03T12:00:00.000Z
- Updated: 2026-09-14T14:27:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156697

*Federal Register* notice: FDA is making available a draft guidance entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” The document provides recommendations to applicants and testing site management on maintaining data integrity for the clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted in support of drug-related submissions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-04-03/pdf/2024-07080.pdf?ref=fdaweb.com).