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几种简单设计的等效性检验的样本量与检验效能 被引量:9

Sample size and power determination for equivalence test in simple designs
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摘要 目的 :探讨一种用于单样本、配对以及两独立样本等简单设计等效性检验的样本量与检验效能的估算方法 .方法 :在介绍Phillips法所依据的原理公式的基础上 ,利用统计软件SAS作实例探讨 ,并与传统的计算等效性检验样本量的公式相比较 .结果 :传统估算等效性检验的样本量的公式必须将两药物的实际差别考虑在内 ,否则将会低估所需要的样本量 ,而Phillips法特别注意了这一点 ,不会出现类似错误 .结论 :利用Phillips法计算几种简单设计的等效性检验的样本量与检验效能 ,与传统公式调整后的计算结果基本一致 。 AIM: To explore Phillips method in calculating the sample size and power in some simple designs such as one sample equivalence test, paired equivalence test and two sample equivalence test. METHODS: According to the theory and formulation of Phillips method, examples were analyzed by SAS program and the results were compared with those by the traditional method. RESULTS: The real difference in simple designs was detected, which had been neglected by traditional methods. CONCLUSION: Compared with the traditional method, Phillips method can more efficiently and accurately analyze samples in simple designs.
出处 《第四军医大学学报》 北大核心 2004年第11期1045-1049,共5页 Journal of the Fourth Military Medical University
关键词 等效性检验 样本量 检验效能 equivalence test sample size power of test
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参考文献8

  • 1Guidance for Industry - Statistical Approaches to Establishing Bioequivalence U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2001 http://www.fda.gov/cder/guidance/index/htm.
  • 2Phillips KF. Power of the two one-sided tests procedure in bioequivalence [J]. J Pharmacokinet Biopharm, 1990; 18(2): 137-144.
  • 3Chapter 56: The Power Procedure (Experimental) :3171~3242 http:// www. support. sas. com/ rnd / app / papers / power.pdf.
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  • 8杜小莉,李大魁,朱珠.生物等效性评价方法的进展[J].中国临床药理学杂志,2000,16(3):220-224. 被引量:24

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