Sethuraman Venkat S, Leonov Sergei, Squassante Lisa, Mitchell Toni R, Hale Michael D
Biostatistics and Statistical Reporting, Novartis Pharmaceuticals, Florham Park, NJ 07932, USA.
Pharm Stat. 2007 Jan-Mar;6(1):35-41. doi: 10.1002/pst.241.
There are several approaches to assess or demonstrate pharmacokinetic dose proportionality. One statistical method is the traditional ANOVA model, where dose proportionality is evaluated using the bioequivalence limits. A more informative method is the mixed effects Power Model, where dose proportionality is assessed using a decision rule for the estimated slope. Here we propose analytical derivations of sample sizes for various designs (including crossover, incomplete block and parallel group designs) to be analysed according to the Power Model.
有几种方法可用于评估或证明药代动力学剂量比例性。一种统计方法是传统的方差分析模型，其中使用生物等效性限度来评估剂量比例性。一种更具信息量的方法是混合效应幂模型，其中使用针对估计斜率的决策规则来评估剂量比例性。在此，我们提出了针对各种设计（包括交叉设计、不完全区组设计和平行组设计）的样本量分析推导，以便根据幂模型进行分析。
