Bioanalytical method validation - Scientific guideline

This 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.

Guideline version EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2** is now superseded by the ICH guideline M10 on bioanalytical method validation and study sample analysis, following its finalisation in July 2022.

Keywords: Validation, method validation, bioanalytical method, analyses, incurred samples reanalysis, ligand binding assays

Document history - Revision 1

Guideline on bioanalytical method validation

AdoptedLegal effective date: 01/02/2012Reference Number: EMEA/CHMP/EWP/192217/2009 Rev.1 Corr.2**Summary:

This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative concentration data used for pharmacokinetic and toxicokinetic parameter determinations. Guidance and criteria are given on the application of these validated methods in the routine analysis of study samples from animal and human studies.

Overview of comments received on 'Guideline on validation of bioanalytical methods' (EMEA/CHMP/EWP/192217/2009)

AdoptedReference Number: EMA/434565/2010Summary:

Interested parties (organisations or individuals) that commented on the draft document as released for consultation.

Draft guideline on validation of bionanalytical methods

Consultation dates: 20/11/2009 to 31/05/2010Draft: consultation closedReference Number: EMEA/CHMP/EWP/192217/2009

Concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods

Reference Number: EMEA/CHMP/EWP/531305/2008