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Guideline version EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2** is now superseded by the ICH guideline M10 on bioanalytical method validation and study sample analysis, following its finalisation in July 2022.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