ICH M10 on bioanalytical method validation

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.

Keywords: Bioanalytical method; Bioanalytics; Validation; Chromatography; ligand binding assay; incurred sample reanalysis

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