TRS 1060 - Annex 6: Guideline on bioanalytical method validation and study sample analysis
15 April 2025
| Technical document
Overview
This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification in biological matrices and their application in the analysis of study samples. Adherence to the principles presented in this guideline will ensure the quality and consistency of the bioanalytical data in support of the development and market approval of both chemical and biological drugs.
WHO Team
Access to Medicines and Health Products (MHP),
Health Product Policy and Standards (HPS),
Norms and Standards for Pharmaceuticals (NSP),
Technical Standards and Specifications (TSS)
Number of pages
56