Shen C F, Iglewicz B
Biometrics Research Department, Merck Research Laboratories, Rahway, New Jersey.
J Biopharm Stat. 1994 Mar;4(1):65-90. doi: 10.1080/10543409408835073.
A common problem encountered in bioequivalence studies is the presence of outliers. In this situation, the two one-sided t-tests proposed by Schuirmann fail to provide reasonable power for concluding bioequivalence. In contrast, our proposed 2 beta trimmed-t procedure has the following advantages: (1) it has higher efficiency for nonnormal symmetric distributions, (2) it is resistant to outliers, and (3) it is relatively easy to compute. Two bootstrap procedures introduced here provide further justification for the proposed trimmed t-test procedure. Results from Monte Carlo studies illustrate the power of the proposed procedures under various distributional assumptions for a 2 x 2 crossover trial.
生物等效性研究中常见的一个问题是存在异常值。在这种情况下，舒尔曼提出的两个单侧t检验无法为得出生物等效性结论提供合理的检验效能。相比之下，我们提出的双β截尾t检验程序具有以下优点：（1）对于非正态对称分布具有更高的效率；（2）对异常值具有抗性；（3）计算相对容易。这里介绍的两种自助法程序为所提出的截尾t检验程序提供了进一步的依据。蒙特卡罗研究的结果说明了所提出的程序在2×2交叉试验的各种分布假设下的检验效能。
