生物分析方法验证及生物样品分析各指导原则间的比较

Comparative Analysis of Guidelines for Bioanalytical Method Validation and Study Sample Analysis

生物分析方法验证能够确保开发的方法稳定可靠,适用于生物样品的分析,进而促进药物的开发和发展。而生物分析方法的规范性也直接影响着生物样品测定的准确性。各国监管机构自20世纪初纷纷建立其生物分析方法指导原则,为更好地促进生物分析规范化的一致性,2022年5月,人用药品技术要求国际协调理事会(The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use,ICH)发布了《M10:生物分析方法验证和研究样品分析》(M10)。本文对生物分析方法的发展进程简单梳理,对M10与目前影响力较大的主要生物分析方法指导原则进行比较,以期推动生物分析方法验证及样品分析的规范化进程。

Bioanalytical method validation ensures that the developed method is robust and suitable for the analysis of biological samples,thereby facilitating drug discovery and development.The standardization of bioanalytical methods directly affects the accuracy of biological sample determination.Although regulators in various countries have made corresponding regulations for the validation of bioanalytical methods since the early 20th century,in order to create uniform rules of regulated bioanalysis,in May 2022,the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH)released M10“Guiding Principles for Validation of Biological Analysis Methods and Sample Analysis”.In this paper,the development process of biological analysis methods will be briefly reviewed first,and M10 will be compared with the current major bioanalysis method guidance with greater influence,with a view to promoting the normalization process of bioanalysis method verification and sample analysis.