ICH M10 on bioanalytical method validation - Scientific guideline
Table of contents
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 series of FAQs.
Keywords: Bioanalytical method; Bioanalytics; Validation; Chromatography; ligand binding assay; incurred sample reanalysis
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ICH guideline M10 on bioanalytical method validation - Step 5 (PDF/585.7 KB)
Adopted
First published: 27/07/2022
Legal effective date: 21/01/2023
EMA/CHMP/ICH/172948/2019 -
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ICH guideline M10 on bioanalytical method validation and study sample analysis – Frequently Asked Questions (FAQ) (PDF/187.36 KB)
Adopted
First published: 27/07/2022
Last updated: 13/01/2023
Legal effective date: 23/01/2023
EMA/CHMP/ICH/660315/2022
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Draft ICH guideline M10 on bioanalytical method validation - Step 2b (PDF/983.34 KB)
Draft: consultation closed
First published: 14/03/2019
Consultation dates: 14/03/2019 to 01/09/2019
EMA/CHMP/ICH/172948/2019 -
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Overview of comments received on 'Draft ICH guideline M10 on bioanalytical method validation - Step 2b' (PDF/1.38 MB)
First published: 30/10/2019
EMA/485652/2019