Biostatistics and Research Decision Sciences, Merck & Co., Inc, North Wales, PA, USA.
Early Development Biostatistics, Novartis Pharmaceuticals Corporation, Cambridge, MA, USA.
J Biopharm Stat. 2020 Mar;30(2):231-243. doi: 10.1080/10543406.2019.1657438. Epub 2019 Aug 27.
The reference scaled bioequivalence has been proposed with many successful applications for the highly variable products. The statistical properties for the reference scaled bioequivalence have been studied for the commonly used crossover design. However, a crossover design may not be feasible in a real application such as the biosimilar study, instead a parallel design is a more timely and cost-effective choice. In this paper, the approximate upper confidence interval limit for the linearized criteria in the reference scaled bioequivalence from a parallel design is derived. The performance of the approximation is evaluated through the simulation. The simulation results show that this approximation performs well and gives reasonable power and well-controlled type I error.
参比缩放生物等效性已经被提出，并在许多高度变异产品的应用中取得了成功。已经针对常用的交叉设计研究了参比缩放生物等效性的统计特性。然而，在实际应用中，交叉设计可能不可行，例如生物类似药研究，而平行设计则是更及时和具有成本效益的选择。在本文中，推导了来自平行设计的参比缩放生物等效性线性化标准的近似上限置信区间限。通过模拟评估了近似的性能。模拟结果表明，这种近似效果很好，并且具有合理的功效和良好的控制的 I 型错误率。
