Jonkman Jeffrey N, Sidik Kurex
Department of Mathematics & Statistics, Grinnell College, Grinnell, Iowa 50112-1690, USA.
J Biopharm Stat. 2009 Sep;19(5):818-37. doi: 10.1080/10543400903105299.
For assay or dose-response data in drug discovery, it is often important to test for parallelism of the response curves for two preparations, such as a test drug and a standard drug, in order to determine the potency of the test preparation relative to the standard preparation. A typical approach is to perform a three-degree of freedom approximate F test of the null hypothesis that the relevant parameters are equal for the two preparations. We argue that this problem may be more appropriately viewed as a practical equivalence testing problem, and present an alternative method for testing parallelism in the four-parameter logistic response curve, based on the theory of intersection-union tests. The approach is intuitively appealing and simple to implement using commonly available software, and may provide more appropriate inference for the problem of interest. Two examples are discussed to illustrate the testing approach outlined in this article, and to compare it with the typical approach to testing parallelism. A simulation study is also presented to compare the empirical properties of the two different testing approaches for a set of cases based approximately on one of the examples.
对于药物研发中的分析或剂量反应数据，为了确定受试制剂相对于标准制剂的效力，检验两种制剂（如受试药物和标准药物）的反应曲线是否平行通常很重要。一种典型的方法是对两个制剂相关参数相等的原假设进行三自由度近似F检验。我们认为这个问题可能更适合看作是一个实际等效性检验问题，并基于交集-并集检验理论，提出一种用于检验四参数逻辑斯蒂反应曲线平行性的替代方法。该方法直观且使用常用软件易于实现，可能为相关问题提供更合适的推断。讨论了两个例子来说明本文概述的检验方法，并将其与检验平行性的典型方法进行比较。还进行了一项模拟研究，以比较基于其中一个例子的一组案例中两种不同检验方法的实证性质。
