关键词: font-size:medium, ">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

Abstract: 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.
    

Key words: Sevelamer carbonate tablets;Bioequivalence；Phosphate binding agents； Phosphate binding, Generic drug development