Bioanalytical method validation

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.

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

Document history - Revision 1 (current version)

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