FDA announces availability of a final guidance entitled M10 bioanalytical method validation

On November 7th, 2022, FDA announced the availability of a final guidance for industry entitled M10 Bioanalytical Method Validation, developed under the direction of the International Council for Harmonisation.

The guidance 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.

Concentration measurements of chemical and biological drug(s) and their metabolite(s) in biological matrices are an important aspect of drug development. The results of studies employing such methods contribute to regulatory decisions regarding the safety and efficacy of drug products.

It is therefore critical that the bioanalytical methods used are well characterized, appropriately validated, and documented to ensure reliable data to support regulatory decisions. The information in this guidance applies to the quantitative analysis by ligand binding assays (LBAs) and chromatographic methods such as liquid chromatography (LC) or gas chromatography (GC), which are typically used in combination with mass spectrometry (MS) detection.

The guidance is intended to provide industry with harmonized regulatory expectations for bioanalytical method validation of assays used to support regulatory submissions. For the bioanalysis of drugs and therapeutic biologics, this guidance replaces the FDA final guidance “Bioanalytical Method Validation” issued May 2018 and the FDA draft guidance “M10 Bioanalytical Method Validation” issued June 2019.

The “M10 Bioanalytical Method Validation” guidance is available here.