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# ICH M10 Guidance Released
- URL: https://www.fdaweb.com/ich-m10-guidance-released/
- Published: 2019-06-27T12:00:00.000Z
- Updated: 2026-09-15T01:35:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144435

FDA has published an International Council on Harmonization guidance, *M10 Bioanalytical Method Validation*, with recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples. “Adherence to the principles presented in this guideline will improve the quality and consistency of the bioanalytical data in support of the development and market approval of both chemical and biological drugs,” the [document](https://www.fda.gov/media/128343/download?ref=fdaweb.com) says.