欢迎访问《中国临床药理学与治疗学》杂志官方网站,今天是

中国临床药理学与治疗学 ›› 2003, Vol. 8 ›› Issue (2): 219-222.

• 设计与统计 • 上一篇    下一篇

新药临床等效性分析方法及其评价

闫宇翔, 王洪源1, 王仁安1   

  1. 首都医科大学公共卫生学院流行病与卫生统计学系, 北京 100054;
    1北京大学公共卫生学院流行病与卫生统计学系, 北京 100083
  • 收稿日期:2002-12-11 修回日期:2003-01-08 出版日期:2003-04-26 发布日期:2020-11-25
  • 通讯作者: 闫宇翔, 女, 硕士。Tel:010-63294209 E-mil:yanyx100@163.com

Analysis method of therapeutic equivalence and its evaluation

YAN Yu-Xiang, WANG Hong-Yuan1, WAN Ren-An1   

  1. Department of Epidemiology and Biostatistics, Capital University of Medical Science, Beijing 100054;
    1Department of Epidemiologyand Biostatistics, School of Public Health, Peking University, Beijing 100083
  • Received:2002-12-11 Revised:2003-01-08 Online:2003-04-26 Published:2020-11-25

摘要: 临床等效性检验是临床试验中评价新药疗效的一种方法, 用于比较两药的疗效是否相当。它弥补了生物等效性评价的不足之处, 目前已被推广使用。本文论述了临床等效性评价中等效界值确定方法、临床终点的选取、试验设计、统计分析等一些关键性问题, 并分析了其研究现状。这对于临床等效性评价方法的正确应用与发展有现实意义。

关键词: 生物统计学, 临床等效性, 等效界值, 目标参数, 试验设计, 统计分析, 评价

Abstract: Therapeutic equivalence test is used to show whether a new drug is effective as a standard drug in the shortage of bioequivalence.The paper discussed some important issues with some examples, such as the choice of equivalence margin, primary endpoint of trials, the design of trials, and statistical analysis in the therapeutic equivalence.The current status of the research was evaluated as well.These are important to the employment and development of therapeutic equivalence.

Key words: biometry, therapeutic equivalence, equivalence margin, target parameter, design of trials, statistical analysis, evaluation

中图分类号: