From Harmonisation to Practice: A Critical Appraisal of the Global Implementation of ICH M10 for Bioanalytical Method Validation and Study Sample Analysis
M. Satwika & Khagga Bhavya Sri · Journal of Advances in Medical and Pharmaceutical Sciences · 2026
Concentration measurements of drugs and their metabolites in biological matrices underpin regulatory decisions on safety, efficacy and labelling, and the technical requirements governing those measurements were, for three decades, set regionally. Guideline M10 of the Internationa...
Open access
Research Article
10.9734/jamps/2026/v28i8882