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与安慰剂比较的同时置信带及其在检测最小有效剂量中的应用。

Simultaneous confidence bands for comparisons to placebo, with application to detecting the minimum effective dose.

作者信息

Soulakova Julia N, Sampson Allan R, Jia Gang, Gleser Leon J

机构信息

Department of Statistics, University of Nebraska-Lincoln, Lincoln, Nebraska 68583-0963, USA.

出版信息

J Biopharm Stat. 2012;22(1):93-108. doi: 10.1080/10543406.2010.504905.

Abstract

In this article we consider a max-min approach to construct two-sided and one-sided simultaneous confidence bands in a dose-response study for the contrast in mean responses of each ascending dose versus placebo. The method utilizes the assumption of monotone non-decreasing dose-response curve. Also discussed is a step-down testing procedure that utilizes the lower bands to estimate the minimum effective dose (MED). The performance of our proposed step-down procedure is assessed by simulations and is shown to be superior to competitors when the MED is the lowest dose in a dose-response study.

摘要

在本文中,我们考虑一种最大-最小方法,用于在剂量反应研究中构建双侧和单侧同时置信带,以对比各递增剂量与安慰剂的平均反应。该方法利用了剂量反应曲线单调非递减的假设。还讨论了一种逐步检验程序,该程序利用下限估计最小有效剂量(MED)。我们提出的逐步程序的性能通过模拟进行评估,结果表明,在剂量反应研究中当MED为最低剂量时,该程序优于其他方法。

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