| 率的等效性检验方法的比较 |
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| 引用本文： | 吕静静,于浩,陈峰.率的等效性检验方法的比较[J].中国临床药理学与治疗学,2004,9(3):354-357. |
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| 作者姓名： | 吕静静 于浩 陈峰 |
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| 作者单位： | 1. 山东省疾病预防控制中心,济南,250014,山东
2. 南京医科大学公共卫生学院流行病与卫生统计学系,南京,210029,江苏 |
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| 摘 要： | 目的 :对 10种率的等效性检验方法的Ⅰ型误差和检验效能进行比较 ,并据此选择较好的方法估计样本含量 ,以便实际工作者应用。方法 :采用MonteCarlo模拟试验。结果 :10种方法中 ,以Dun nett Gent方法为最佳 ,并按该方法估计了样本含量。模拟试验表明 ,率的等效性检验所需要的样本含量非常大 ,当试验组和参考组各只有 10 0例时 ,任何等效性检验方法的检验效能均较低。结论 :按目前国家食品药品监督管理局规定的最低样本含量 10 0对 ,相应的检验效能很低 ,建议用统计学方法进行估计。
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| 关 键 词： | 百分率 等效性检验 检验效能 样本含量 Monte Carlo |
| 文章编号： | 1009-2501(2004)03-0354-04 |
| 修稿时间： | 2003年11月3日 |
Comparison of testing approaches to establishing equivalence on proportions |
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| LU Jing Jing,YU Hao ,CHEN Feng CDC of Shandong province,Jinan,Shandong,China.Comparison of testing approaches to establishing equivalence on proportions[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2004,9(3):354-357. |
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| Authors: | LU Jing Jing YU Hao CHEN Feng CDC of Shandong province Jinan Shandong China |
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| Institution: | LU Jing Jing,YU Hao 1,CHEN Feng 1 CDC of Shandong province,Jinan,250014,Shandong,China, 1 Department of Epidemiology and Biostatistics,Nanjing Medical University,Nanjing 210029,Jiangsu,China |
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| Abstract: | Using Monte Carlo simulation to compare different test approaches, the results showed that Dunnett Gent method was the best one of them both in type I error controlling and test power, and the statistical powers are very lower for all of 10 equivalence test methods when test group and reference group has only 100 cases. When establishing equivalence, 100 cases for each group suggested by State Food and Drug Administration (SFDA) is insufficiency, the required sample size should be estimated by statistical procedure. |
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| Keywords: | test of equivalence on proportions power sample size |
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