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.
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.
刘霏霏;闫方;宋晓;王骏
国家药品监督管理局药品审评中心,北京 100076
药学
循环系统药物;口服固体制剂仿制药;生物等效性研究
circulatory system drugs;oral solid preparation generic drugs;bioequivalence studies
《中国临床药理学杂志》 2024 (005)
778-784 / 7
10.13699/j.cnki.1001-6821.2024.05.031
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