创新药物研发中的立题问题与临床研究原则  

Key problems in the development of innovative drugs——scientific rationale and principle requirement of clinical studies

作　　者：王水强[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11期930-932,共3页Chinese Journal of New Drugs

摘　　要：在创新药的开发过程中,立题直接关系到研究的成败,必须予以特别关注。在确定立题后,必须做好临床开发计划,对药品的安全、有效性进行系统评价。本文对创新药立题、临床研究的原则要求进行了探讨,旨在提高研发效率。The establishment of scientific rationale is one of the most important things during the developmental process of innovative drugs.Overall clinical development program should be designed after the identification of scientific rationale,in order to make a systemic and comprehensive evaluation about the efficacy and safety of the drug.This article discussed the scientific rationale and principle requirement of clinical studies in order to improve the efficiency of development for innovative drugs.

关 键 词：创新药 立题依据 临床研究 

分 类 号：R95[医药卫生—药学]