Abstract

Bioanalytical method validation is essential across pharmaceutical development, covering diverse analytes and methodologies. This collection addresses the rigorous validation of UHPLC-MS/MS methods for small molecules, large molecules, and specialized products like gene therapies and biomarkers. It explores challenges such as matrix effects, chiral drug quantification, and Dried Blood Spot samples, alongside the impact of automation. The consensus underlines the critical need for tailored, reliable validation processes to ensure data integrity, regulatory compliance, and patient safety in clinical and preclinical studies.