阿司匹林肠溶片的生物等效性试验设计要点及审评考虑  

The bioequivalence study design and review consideration of aspirin enteric-coated tablets

作　　者：王静 李丽 陈思 翟颖奇 高恬恬 苑如 王骏 WANG Jing;LI Li;CHEN Si;ZHAI Ying-qi;GAO Tian-tian;YUAN Ru;WANG Jun(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2022年第23期2361-2364,共4页Chinese Journal of New Drugs

摘　　要：阿司匹林为水杨酸类环氧酶抑制剂,可有助于降低心肌梗死复发、预防短暂性脑缺血发作等。阿司匹林肠溶片是国内外企业仿制开发的重要产品之一,本文通过梳理国内外药品监管机构对阿司匹林肠溶片生物等效性(bioequivalence,BE)试验技术要求,结合近年来我国阿司匹林肠溶片BE试验研究现状,初步分析该产品BE试验设计和评价的关键要素,根据审评过程中遇到的实际情况提出一般考虑,以期为该产品仿制药研发提供依据与参考。Aspirin is classified as a salicylic acid cyclooxygenase inhibitor,which can help reduce the recurrence of myocardial infarction and prevent transient ischemic attack.The formulation of aspirin enteric coated tablets is one of the important drug imitated and developed by domestic and foreign enterprises.In this paper,by sorting out the requirements of domestic and foreign drug regulatory authorities for the bioequivalence(BE)test of aspirin enteric coated tablets,and combining the present situation of BE studies of aspirin enteric coated tablets in China in recent years,we preliminarily analyze the key elements of BE study design and evaluation of aspirin,putting forward general considerations in combination with the actual situation encountered in the review process.It is expected to provide basis and reference for the research and development of generic drugs of aspirin enteric coated tablets.

关 键 词：阿司匹林肠溶片 环氧酶抑制剂 仿制药 生物等效性研究 

分 类 号：R969.4[医药卫生—药理学]