摘要
碳酸司维拉姆片为磷结合剂,属于胃肠道局部作用药物,国内外药品监管机构均推荐采用体外磷酸盐结合研究方法来考察其生物等效性。体外磷结合研究通过动力学结合研究以及平衡结合研究来评估受试制剂和参比制剂结合磷酸盐的速度和能力。本研究基于国家药品监督管理局以及美国食品药品管理局(FDA)、欧洲药品管理局(EMA)发布的相关技术指导原则,总结碳酸司维拉姆片体外磷结合生物等效性研究的要点,同时将其与碳酸镧咀嚼片和醋酸钙片进行对比,分析试验设计出发点,提出物质检测方法及要点、生物等效性评价指标及结果分析,以期为此类药物的仿制药研究提供一定参考。
Sevelamer carbonate is a phosphate binding agent,locally acting in the gastrointestinal tract.Domestic and foreign drug regulatory agencies recommend the in vitro phosphate binding study to investigate its bioequivalence.In vitro phosphate binding study can examine the rate and ability of the phosphate binding for the test drug and the reference drug by in vitro equilibrium binding study and in vitro kinetic binding study.With reference to the related technical guidelines of NPMA,FDA and EMA,this paper summarizes the technical points of in vitro phosphate binding bioequivalence study of sevelamer carbonate tablets,analyzes the starting point of the experiment design by comparing with lanthanum carbonate chewable tablets and calcium acetate tablets,puts forward substance detection methods and key points,bioequivalence evaluation indicators and result analysis,in order to provide reference for the generic drug development of phosphate binding agents.
作者
刘淑洁
张丹
马婧怡
李芳
王克栈
刘力力
贺锐锐
LIU Shujie;ZHANG Dan;MA Jingyi;LI Fang;WANG Kezhan;LIU Lili;HE Ruirui(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国医药导刊》
2021年第11期877-880,共4页
Chinese Journal of Medicinal Guide
关键词
碳酸司维拉姆片
生物等效性
磷结合剂
磷酸盐结合
仿制药研究
Sevelamer carbonate tablets
Bioequivalence
Phosphate binding agents
Phosphate binding
Generic drug development
