中药新药研发关键问题思考——以骨质疏松症为例  

Thinking on key issues in research and development of new drugs of traditional Chinese medicine,taking osteoporosis as an example

作　　者：元唯安[1] YUAN Wei-an(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China)

机构地区：[1]上海中医药大学附属曙光医院,上海200021

出　　处：《中国新药杂志》2020年第16期1836-1840,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2017ZX09304-002)。

摘　　要：随着中药新药研发相关新的法律法规出台及实施,中药新药研发的大环境发生了深刻变化,需要中药新药研发相关人员敏锐把握前沿变化,对既往研发模式及技术评价方法做出相应改变,以适应新形势下的研发要求。本文以骨质疏松症中药新药研发为例,通过阐述如何“以临床价值为导向”,开展研究立项可行性评估、临床价值定位确定、试验设计关键问题分析、风险评估以及质量保证,以期共同提高我国中药新药研究水平。With the introduction and implementation of new laws and regulations related to the research and development of new traditional Chinese medicine,profound changes have taken place in the general environment for the research and development of new traditional Chinese medicine.It is necessary for relevant personnel in the field of research and development to grasp the frontier trends and make corresponding changes to the previous research and development mode and technical evaluation method to adapt to the research and development requirements under the new situation.Taking the research and development of new traditional Chinese medicine for osteoporosis as an example,this paper expounded how to carry out feasibility assessment,determination of clinical value orientation,analysis of key issues in experimental design,risk assessment and quality assurance of research projects to jointly improve the research level of new traditional Chinese medicine in China.

关 键 词：中药新药 骨质疏松症 研发 

分 类 号：R95[医药卫生—药学]