| 新药临床等效性分析方法及其评价 |
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| 引用本文： | 闫宇翔,王洪源,王仁安. 新药临床等效性分析方法及其评价[J]. 中国临床药理学与治疗学, 2003, 8(2): 219-222 |
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| 作者姓名： | 闫宇翔 王洪源 王仁安 |
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| 作者单位： | 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
2. 北京大学公共卫生学院流行病与卫生统计学系,北京,100083 |
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| 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相当，它弥补了和一物等效性评价的不足之处，目前已被推广使用，本论述了临床等效性评价中等效果值确定方法，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。
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| 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 |
| 文章编号： | 1009-2501(2003)02-0219-04 |
| 修稿时间： | 2002-12-11 |
Analysis method of therapeutic equivalence and its evaluation |
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| YAN Yu Xiang,WANG Hong Yuan ,WAN Ren An. Analysis method of therapeutic equivalence and its evaluation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2003, 8(2): 219-222 |
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| Authors: | YAN Yu Xiang WANG Hong Yuan WAN Ren An |
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| Affiliation: | YAN Yu Xiang,WANG Hong Yuan 1,WAN Ren An 1 Department of Epidemiology and Biostatistics,Capital University of Medical Science,Beijing 100054, 1 Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100083 |
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| 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. |
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| Keywords: | biometry therapeutic equivalence equivalence margin target parameter design of trials statistical analysis evaluation |
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