Assessing the similarity of dose response and target doses in two non-overlapping subgroups

Abstract

We consider two problems that are becoming more and more frequent in 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. The proposed methods are illustrated with a real case study and their operating characteristics (coverage probabilities, Type I error rates, power) are investigated via simulation.

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ORCID for Wei Liu: orcid.org/0000-0002-4719-0345

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