ICH M10 on bioanalytical method validation

The draft ICH guidance is currently out for review. This proposed new multidisciplinary guideline will address the validation of bioanalytical assays. This guideline will provide recommendations on how to validate a bioanalytical assay for drug quantification and how to apply validation during study sample analysis. However, this guideline does not provide recommendations which analyte should be analysed. This is covered in other ICH and regional regulatory documents.

The draft looks at:

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.

See: https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology