摘要
目的:药物研发过程中的药代动力学研究一般需要进行生物样品药物浓度检测,检测方法的准确性、可靠性、科学性十分重要,其中基质效应考察是检测方法验证体系中的重要组成部分。本文通过调研ICH、NMPA、FDA和EMA相关法规和指导原则,检索国内外基质效应有关文献,结合实际生物样品药物浓度检测方法学验证中基质效应考察的案例,探讨基质效应产生的原因及解决方案,生物样品药物浓度检测中基质效应考察的方法,从而保证基质效应考察的合规性,生物样品药物浓度检测方法学验证规范化,检测结果的可靠性和准确性,以实现生物样品药物浓度检测方法的最优化。
In the process of drug development,the bioanalytical is required generally in pharmacokinetic studies.The accuracy,reliability,and scientificity of bioanalytical method validation are crucial,the investigation of matrix effects has become an important part of the validation system for bioanalytical methods.This article investigated related guidelines from ICH,NMPA,FDA and EMA,searching the related domestic and foreign literature on matrix effect,combining with the case study of matrix effect in actual review,to discuss the method of investigating the matrix effect in the methodological verification of drug concentration detection in unknown biological samples,to clarify the causes and solutions of matrix effect.So as to ensure the standardization of the methodological verification of drug concentration detection in unknown biological samples and the accuracy of the test results,to achieve the optimization of drug concentration detection methods for biological samples.
作者
刘霏霏
王玉珠
LIU Fei-fei;WANG Yu-zhu(Center of Drug Evaluation,National Medical Products Administration,Beijing 100076,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2024年第11期1944-1950,共7页
Chinese Journal of Pharmaceutical Analysis
关键词
药物浓度检测
生物样品
基质效应
指导原则
案例分析
drug concentration detection
biological sample
matrix effect
guidance
case analysis
