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# ICH M10 Bioanalytical Method Analysis Q&A Guidance
- URL: https://www.fdaweb.com/ich-m10-bioanalytical-method-analysis-q-a-guidance/
- Published: 2024-06-13T12:00:00.000Z
- Updated: 2026-09-14T14:33:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157176

FDA has published an International Council for Harmonization guidance, *M10 Bioanalytical Method Validation and Study Sample Analysis Questions and Answers*, in response to questions posed to the M10 draft guidance. The [document](https://www.fda.gov/media/179296/download?attachment&ref=fdaweb.com) says it was created to provide clarity around some of the bioanalytical issues covered in the guidance.

“This question-and-answer document is intended to provide additional clarification and to promote convergence and improve harmonization of the bioanalytical method validation and study sample analysis,” the Q&A guidance says.