内源性药物生物等效性试验规程管理  

Management of bioequivalence trials for endogenous agents

作　　者：刘静[1] 徐明[1] 刘红娇 周发俊 刘川 LIU Jing;XU Ming;LIU Hong-jiao;ZHOU Fa-jun;LIU Chuan(China Pharmaceutical Unieriry,Nanjing 210009,China;Beijing Clinical Sernfice Center,Beijing 100024,China)

机构地区：[1]中国药科大学,南京210009 [2]北京科林利康医学研究有限公司,北京100024

出　　处：《中国新药杂志》2021年第3期205-208,共4页Chinese Journal of New Drugs

基　　金：广州市民生科技攻关计划资助研究课题(201803010036)。

摘　　要：作为机体内原有的物质,因自身调节机制,外源性成分、机体内源性物质水平等多种干扰因素,内源性药物生物等效性试验方案设计复杂,增加试验实施难度。本文从受试者的选择和管理、饮食饮水的控制、样本采集、安全监护方面,对试验实施的难点及特殊性进行分析,总结和探讨质量控制措施,对内源性药物生物等效性临床试验执行管理提供参考。Endogenous substances naturally exist in biological bodies. Due to self-regulation mechanism,exogenous substances and the level of endogenous substances,the design of endogenous drugs bioequivalence test becomes complicated and the trails are difficult to implement. From perspectives of good clinical practice,this article analyzes the difficulties and particularities in the aspects of subject selection and management,diet and drinking water management,sample collection and safety management. This paper also summarizes and discusses quality control measures,providing reference for execution management of endogenous drugs bioequivalence trial.

关 键 词：生物等效性 临床管理 内源性药物 受试者管理 

分 类 号：R969.3[医药卫生—药理学]