FDA Adopts ICH Final Guidance On Bioanalytical Method Validation

Introduction: Toward the end of 2022, the FDA issued guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis.1 The guidance was originally issued in draft form in 2019; a little over three years was required to develop the final guidance document, and it was approved by ICH in May 2022. Hence, the FDA adoption completes international acceptance of a unified approach to biological assays. The objective of issuing the document was to address some concerns with regulatory submissions, and the document provides a set of recommendations for method validation for bioanalytical assays for nonclinical and clinical studies. As well as full validation, the guidance extends to partial validation where modifications are undertaken for previously validated assays. There is an additional intention centered on reducing the numbers of animals used in drug research and development.

This article considers the core objectives of the guidance and how it applies to both GMP and GLP activities.

Best Practices • Guidances • Methods • Regulatory • Testing