Authors: Bretz, Frank
Möllenhoff, Kathrin
Dette, Holger
Liu, Wei
Trampisch, Matthias
Title: Assessing the similarity of dose response and target doses in two non-overlapping subgroups
Language (ISO): en
Abstract: We consider two problems that are attracting increasing attention in clinical dose finding studies. First, we assess the similarity of two non-linear regression models for two non-overlapping subgroups of patients over a restricted covariate space. To this end, we derive a confidence interval for the maximum difference between the two given models. If this confidence interval excludes the equivalence margins, similarity of dose response can be claimed. Second, we address the problem of demonstrating the similarity of two target doses for two non-overlapping subgroups, using again a confidence interval based approach. We illustrate the proposed methods with a real case study and investigate their operating characteristics (coverage probabilities, Type I error rates, power) via simulation.
Subject Headings: equivalence testing
subgroup analyses
target dose estimation
multiregional trial
URI: http://hdl.handle.net/2003/35138
http://dx.doi.org/10.17877/DE290R-17185
Issue Date: 2016
Appears in Collections:Sonderforschungsbereich (SFB) 823

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