Bioanalytical method validation

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMEA/CHMP/EWP/192217/2009 Rev. 1
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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