中国临床药理学杂志2024，Vol.40Issue(5)：778-784,7.DOI:10.13699/j.cnki.1001-6821.2024.05.031
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
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分类
医药卫生引用本文复制引用
刘霏霏,闫方,宋晓,王骏..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[J].中国临床药理学杂志,2024,40(5):778-784,7.
