循环系统药物口服固体制剂仿制药生物等效性研究考虑要点
Considerations on the bioequivalence study of oral solid preparation generic drugs in the circulatory system
刘霏霏 1闫方 1宋晓 1王骏1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
本文以我国生物等效性研究相关指导原则为主要依据,参考国际先进监管机构相关要求,结合循环系统药物的特点,对循环系统药物口服固体制剂仿制药生物等效性研究给出几点考虑.
Abstract
Drawing upon the relevant guidances on the bioequivalence study in China,referring to the requirements of international advanced supervision organization,considering the characteristics of the circulatory system drugs,this paper provides several considerations on the bioequivalence studies of the oral solid preparation generic drugs in the circulatory system.
关键词
循环系统药物/口服固体制剂仿制药/生物等效性研究Key words
circulatory system drugs/oral solid preparation generic drugs/bioequivalence studies引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据