药学研究2024，Vol.43Issue(6)：564-567,4.DOI:10.13506/j.cnki.jpr.2024.06.008
《化学仿制药晶型研究技术指导原则(试行)》解读
Interpretation of ″Guidance on Polymorphism Study of Chemical Generic Drugs(Trial)″
杨柳 1何艳 1胡玉玺 1许真玉1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100022
- 折叠
摘要
Abstract
In recent years,polymorphism study of chemical drugs has become a research hotspot in the international pharmaceutical field,in order to encourage and promote the development of chemical generic drugs in domestic pharmaceutical enterprises,and clarify the focus of crystal research in the process of chemical generic drug research and development,the Center for Drug Evaluation of National Medical Products Administration officially issued the"Guideline on Polymorphism Study of Chemical Generic Drugs(Trial)"on January 4,2022.A detailed interpretation of the guidance is provided in this paper,combined with the drafting process of the guidance and fully considering the characteristics of generic drug development,in order to help applicants to get a better understanding and application.关键词
化学仿制药/晶型研究/技术指南/解读Key words
Chemical generic drugs/Polymorphism/Guidance/Interpretation分类
药学引用本文复制引用
杨柳,何艳,胡玉玺,许真玉..《化学仿制药晶型研究技术指导原则(试行)》解读[J].药学研究,2024,43(6):564-567,4.
