中国药物评价2023，Vol.40Issue(6)：470-479,10.
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
摘要
Abstract
Bioanalytical method validation ensures that the developed method is robust and suitable for the analysis of biological sam-ples,thereby facilitating drug discovery and development.The standardization of bioanalytical methods directly affects the accuracy of bio-logical sample determination.Although regulators in various countries have made corresponding regulations for the validation of bioanalyti-cal 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 promo-ting the normalization process of bioanalysis method verification and sample analysis.关键词
生物分析方法验证/生物样品分析指导原则/M10/色谱法/配体结合法Key words
Guidance on bioanalysis/Bioanalytical methodvalidation/M10/Chromatography Assays/Ligand Binding Assays分类
医药卫生引用本文复制引用
叶潇,郑爽,林超,黄舒佳,王宇,于敏,刘颖..生物分析方法验证及生物样品分析各指导原则间的比较[J].中国药物评价,2023,40(6):470-479,10.基金项目
中国食品药品检定研究院关键技术研究基金(GJJS-2022-9-1) （GJJS-2022-9-1）
