M10 Bioanalytical Method Validation and Study Sample Analysis

4 November 2022 – FDA published the final guidance on M10 bioanalytical method validation and study sample analysis.

The guidance provides recommendations for method validation for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions, including the procedures and processes for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects.

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