ICH M10 on bioanalytical method validation - Scientific guideline
HumanScientific guidelines
Concentration measurements of chemical and biological drug(s) and their metabolite(s) in biological matrices are used as part of regulatory decisions regarding the safety and efficacy of drug products. It is therefore critical that the bioanalytical methods used are well characterised, appropriately validated and documented in order to ensure reliable data to support regulatory decisions. The objective of the validation of a bioanalytical assay is to demonstrate that it is suitable for its intended purpose. This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.
To support the implementation of ICH M10, the Expert Working Group has developed a ICH guideline M10 on bioanalytical method validation and study sample analysis – Frequently Asked Questions (FAQ).
In addition to the FAQs, a strategy has been developed to address specific considerations to enable its implementation in practice:
Implementation strategy of ICH Guideline M10 on bioanalytical method validationThe comments received in the public consultation that ended 31 January 2024 have been published:
Overview of comments received on Implementation strategy of ICH Guideline M10 on bioanalytical method validation EMA/449486/20233Keywords: Bioanalytical method; Bioanalytics; Validation; Chromatography; ligand binding assay; incurred sample reanalysis