Bioanalytical method validation

Current effective version

PDF iconRevision 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/02/2012–present


Published: 01/08/2011


Published: 07/12/2009


Published: 18/12/2008


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