摘要
通过对近年来在我国申报的创新性化学药品申请项目的审评情况以及不批准的原因进行系统分析,探求导致创新药研发失败的主要因素。分析结果显示,在11.4%不批准的创新性药品申请中,41%为临床定位不合理,29%为临床前安全性结果不支持临床方案。
We systemically analyzed the review results and failed reasons in applications for investigational new drugs. The aim of this paper was to analyze the main factors that led to failures in the research and development of new drugs. The results have shown that 11.4% applications were not approved by SFDA, in which 41% applications had no suitable and good clinical advantages, 29% applications had no adequate and good preclinical safety data to support the clinical trials.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2010年第1期17-19,共3页
Chinese Journal of New Drugs
关键词
创新性药物
研发
失败
investigational new drug
research and development
failure
