Bioanalytical method validation

  • Email
  • Help
Current effective version

Revision 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

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

Related content

How helpful is this page?

Average rating:

 Based on 31 ratings

Add your rating:

See all ratings
6 ratings
6 ratings
6 ratings
6 ratings
7 ratings

Tell us more