摘要
CMC阶段的研究是药物研发的重要方面,但是创新药物和仿制药物的CMC阶段研究有一定的区别,通过对两者CMC研究区别的分析,说明了创新药物研发中CMC进行阶段性要求的必要性,阐述了目前创新药物CMC研究存在的主要问题,明确了药物研发各阶段CMC研究应关注的重点。
CMC research is a very important aspect in drug research and development. In this article, we analyzed the difference in CMC research between new drug and generic drugs, and explained the necessity of different requirements of CMC research in new drugs＇ development period, and illuminated the main problems and emphases in new drug CMC research.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2010年第2期95-97,105,共4页
Chinese Journal of New Drugs
关键词
创新药物
CMC阶段研究
研发
new drug
CMC research
research and development
