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《Chinese New Drugs Journal》 2003-05
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Sample size estimation and equivalence margin in noninferiority and equivalence trials

ZHENG Qing-shan1,SUN Rui-yuan1,CHEN Zhi-yang2 (1 Anhui Provincial Center for Drug Clinical Evaluation & Yijishan Hospital of Wannan Medical College,Wuhu 241001,China;2 Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)  
Based on the character and requirement of new drug clinical trials,a simple algorithm for sample size estimation and some methods for determination of equivalence margin (δ) in noninferiority and equivalence clinical trials were provided in this paper.
【CateGory Index】: R969.4
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