CMIC：2023年生物分析方法验证：全球协调系统（ICH M10）的挑战与机遇报告（英文版）

Over the past 13 years, regional scientific associations have collaborated to harmonize global bioanalytical guidelines through the Global Bioanalysis Consortium. Their input helped to shape ICH M10, a new set of guidelines that have been approved by the ICH and adopted by regulatory agencies. They provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples. For drug developers, ICH