首页|左氧氟沙星片生物等效性试验豁免的考虑

左氧氟沙星片生物等效性试验豁免的考虑

扫码查看
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。
Consideration of bioequivalence test waiver of Levofloxacin Tablets
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 ap-plication route for research unit.

Levofloxacin TabletsBioequivalence testWaiverSpecifications

赵磊

展开 >

国家药品监督管理局药品审评中心,北京 100076

左氧氟沙星片 生物等效性试验 豁免 规格

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(12)