Introduction and analysis of overseas and domestic bioequivalence guidances for injection products
10.13699/j.cnki.1001-6821.2018.06.032
- VernacularTitle:国内外特殊注射剂生物等效性指导原则的介绍分析
- Author:
Qian LIU
1
;
De-Jun CHEN
;
Xiao-Yan WANG
;
Tian YU
;
Nan NAN
;
Ming-Di XU
Author Information
1. 中国食品药品检定研究院仿制药质量研究中心
- Keywords:
bioequivalence study;
guidance;
reference product;
injection;
agreement evaluation of generic drug products
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(6):717-724
- CountryChina
- Language:Chinese
-
Abstract:
Bioequivalence (BE) study is one of the critical factors for evaluating the inherent quality of generic drug products.U.S.Food and Drug Administration (FDA) and European Medicines Agency (EMA) issued guidance on Bioequivalence Recommendations for Specific Products related with injection production were studied and analyzed.Recommendations were analyzed from multiple aspects,including study design,selection of bioequivalence subjects,dosage,analytes to measure,waiver request of in vivo testing,in vitro test,etc.These guidances have important inspiration of the agreement evaluation of generic drug products in China.
