[摘要] 探索性新药临床研究(0期临床实验)在国外已经开始运用于新药开发，这种研究模式具有一定的优势，对我国创新药物开发颇有意义，为此探讨探索性新药临床研究的概念、原则、优势，分析其目前在国外研究概况，并对开发运用探索性新药临床研究模式存在的问题进行思考。

 [关键词] 探索性新药研究；创新药物；0期临床试验；eIND

 [中图分类号] R969.4 [文献标识码] B [文章编号] 1673-7210(2012)02(b)-0152-02

 Discussion on the exploratory investigational new drug

 WU Maolin DENG Jing

 Department of Oncology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan Province, Chengdu 610075, China

 [Abstract] Exploratory investigational new drug (eIND) study (0 clinical trials) has been used in explorering new drugs in foreign, the study model has some advantages, it is quite significant for the development of innovative drugs in China, therefore, we discuss the concepts, the principles and the advantages about the eIND, and analyze the current overview in foreign about eIND, and discuss some questions about the study model of eIND.

 [Key words] Exploratory investigational new drug; Innovative drugs; 0 clinical trials; eIND

 在创新药物研发中传统意义上的新药临床实验Ⅰ~Ⅳ期已经为广大研发机构、科研人员所熟悉 ...... 第 1 2 页 下一页
 百拇医药网 http://www.100md.com/html/paper/1673-0089/2012/05/69.htm
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