创新药研发中0期临床试验的相关问题探讨  

Related issues in phase 0 clinical trials in research and development of investigational new drugs

作　　者：杨志敏[1] 孙涛[1] 赵德恒[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2010年第9期743-745,共3页Chinese Journal of New Drugs

摘　　要：通过对近年来在创新药研发领域中出现的0期临床试验的产生背景、研究思路和方法等相关问题进行阐述和分析,说明不断借鉴先进国家和地区在创新药研发技术新成果的精华,将会使我国创新药研发能力提高得更快更稳健。In this paper,phase 0 clinical trials were systemically described and analyzed based on the background,research thinking and methods in research and development of investigational new drugs.The new skills of international pharmaceutical companies could improve research and development of new drugs more rapidly and steadily.

关 键 词：创新性药物 临床试验 0期 微剂量 

分 类 号：R95[医药卫生—药学]