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Bootstrap and MLS Methods-based Individual Bioequivalence Assessment

Authors: Kongsheng Zhang, Li Ge


It is a one-sided hypothesis testing process for assessing bioequivalence. Bootstrap and modified large-sample(MLS) methods are considered to study individual bioequivalence(IBE), type I error and power of hypothesis tests are simulated and compared with FDA(2001). The results show that modified large-sample method is equivalent to the method of FDA(2001) .

Keywords: bootstrap, Individual bioequivalence, Bayesian bootstrap, modified large-sample

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