临床试验用药品管理模式的探讨  

Management mode investigation of drugs used for clinical trials

作　　者：刘妤[1] 陆明莹[1] 张田香[1] 张彩霞[1] 刘婷[1] 袁祖贻[1] 

机构地区：[1]西安交通大学第一附属医院药物临床试验机构办公室,陕西西安710061

出　　处：《中国新药与临床杂志》2017年第9期522-525,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：试验用药品管理是药物临床试验管理的关键环节之一,关系到整个药物临床试验的质量。如何科学、规范的管理试验用药品一直是临床试验机构不断探索的问题。本文总结试验用药品管理中的关键环节,分析各种管理模式的利弊,以期为试验用药品管理模式的建立提供借鉴。The management of investigational product is one of the key links for the clinical trials, and it is related to the quality of the whole clinical trials. How to manage the investigational product scientifically and standardly is always a problem for the clinical trial institution to explore continuously. This article summarized the key points in investigational product management and analysed the advantages and disadvantages of various management modes, in order to provide reference for the establishment of investigational product management for clinical trials.

关 键 词：临床试验 药物临床试验质量管理规范 试验用药品 管理 

分 类 号：R954[医药卫生—药学]