Bioanalytical method validation

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMEA/CHMP/EWP/192217/2009 Rev. 1
Published01/08/2011
Effective from01/02/2012
KeywordsValidation, method validation, bioanalytical method, analyses, incurred samples reanalysis, ligand binding assays
DescriptionThis document defines key elements necessary for the validation of bioanalytical methods. It focuses on the validation of the bioanalytical methods generating quantitative concentration data used for pharmacokinetic and toxicokinetic parameter determinations. It also provides guidance on the application of these validated methods in the routine analysis of study samples from animal and human studies.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/02/2012–present


Published: 01/08/2011


Published: 07/12/2009


Published: 18/12/2008


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