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# Guide on Bioanalytical Method Validation
- URL: https://www.fdaweb.com/guide-on-bioanalytical-method-validation-2/
- Published: 2022-11-07T12:00:00.000Z
- Updated: 2026-09-14T18:05:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153137

*Federal Register* notice: FDA has made available a final guidance entitled “M10 Bioanalytical Method Validation and Study Sample Analysis.” The International Council for Harmonization document describes recommendations for method validation for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions, including the procedures and processes that should be characterized for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-11-07/pdf/2022-24113.pdf?ref=fdaweb.com).