Considerations on the bioequivalence study of oral solid preparation generic drugs in the circulatory system
10.13699/j.cnki.1001-6821.2024.05.031
- VernacularTitle: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
- Author:
Fei-Fei LIU
1
;
Fang YAN
;
Xiao SONG
;
Jun WANG
Author Information
1. 国家药品监督管理局药品审评中心,北京 100076
- Keywords:
circulatory system drugs;
oral solid preparation generic drugs;
bioequivalence studies
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(5):778-784
- CountryChina
- Language:Chinese
-
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.
