The bootstrap and Bayesian bootstrap method in assessing bioequivalence |
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| Authors: | Wan Jianping Zhang Kongsheng Chen Hui |
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| Institution: | aDepartment of Mathematics, Huazhong University of Science and Technology, Wuhan 430074, PR China;bInstitute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, PR China;cCollege of Statistics and Mathematics of Anhui Finance and Economics University, Bengbu 233030, PR China |
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| Abstract: | Parametric method for assessing individual bioequivalence (IBE) may concentrate on the hypothesis that the PK responses are normal. Nonparametric method for evaluating IBE would be bootstrap method. In 2001, the United States Food and Drug Administration (FDA) proposed a draft guidance. The purpose of this article is to evaluate the IBE between test drug and reference drug by bootstrap and Bayesian bootstrap method. We study the power of bootstrap test procedures and the parametric test procedures in FDA (2001). We find that the Bayesian bootstrap method is the most excellent. |
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