左氧氟沙星片生物等效性试验豁免的考虑  

Consideration of bioequivalence test waiver of Levofloxacin Tablets

作　　者：赵磊 ZHAO Lei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药学研究》2024年第12期1196-1199,共4页Journal of Pharmaceutical Research

摘　　要：左氧氟沙星片是仿制药申报和一致性评价的热门品种。本文就左氧氟沙星片生物等效性试验豁免的政策法规以及指导原则进行了论述,总结了不同规格的左氧氟沙星片生物等效性试验豁免的技术要求,旨在为研究单位提供更好的研发和申报思路。Generic drug application and consistency evaluation of Levofloxacin Tablets are popular in recent years.This article discussed the policies and guiding principle of bioequivalence test waiver,and summarized the technical requirements of bioequivalence test waiver for different specifications of Levofloxacin Tablets,in order to provide better research and application route for research unit.

关 键 词：左氧氟沙星片 生物等效性试验 豁免 规格 

分 类 号：R95[医药卫生—药学]