Hauck W W, Hauschke D, Diletti E, Bois F Y, Steinijans V W, Anderson S
Biostatistics Section, Division of Clinical Pharmacology, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA.
J Biopharm Stat. 1997 Mar;7(1):179-89. doi: 10.1080/10543409708835178.
An open question in the analysis of average bioequivalence is whether the nonparametric (Wilcoxon) or parametric (t) approaches to two one-sided tests is preferable. Previous work has made particular distributional assumptions as to the distribution of AUC and C(max). Instead, we simulate data according to a pharmacokinetic model for an immediate-release formulation. We find that both approaches have estimated level consistent with the nominal 5%. The only concern is a possible anticonservativeness of the parametric approach for C(max). Further, the nonparametric approach is consistently less powerful than the parametric for the cases studied.
在平均生物等效性分析中，一个悬而未决的问题是，在两个单侧检验中，非参数（威尔科克森）方法还是参数（t）方法更可取。先前的研究对AUC和C(max)的分布做出了特定的分布假设。相反，我们根据速释制剂的药代动力学模型模拟数据。我们发现，两种方法估计的水平均与名义上的5%一致。唯一需要关注的是，参数方法对于C(max)可能存在反保守性。此外，在所研究的案例中，非参数方法的效力始终低于参数方法。
