Xiao W, Barron A M, Liu J
The American University, Washington, D.C. 20016, USA.
J Biopharm Stat. 1997 Mar;7(1):135-55. doi: 10.1080/10543409708835175.
This study investigates the robustness of Schuirmann's two one-sided tests procedure under a set of Box-Cox alternatives. A simulation is conducted to study the level of significance and the power of the procedure. Empirical results show that Schuirmann's procedure is robust under Box-Cox alternatives when the mean of the underlying distribution of the reference formulation is known, which suggests that the assumptions of normality or lognormality are sufficient but may not be necessary. It appears that Schuirmann's procedure cannot maintain the proper level of significance when the mean of the reference formulation is unknown, even under the normality or lognormality assumptions.
本研究考察了Schuirmann双侧检验程序在一组Box-Cox备择假设下的稳健性。进行了一项模拟研究该程序的显著性水平和功效。实证结果表明，当参比制剂潜在分布的均值已知时，Schuirmann程序在Box-Cox备择假设下是稳健的，这表明正态性或对数正态性假设是充分的，但可能不是必要的。当参比制剂的均值未知时，即使在正态性或对数正态性假设下，Schuirmann程序似乎也无法维持适当的显著性水平。
