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

dc.contributor.authorBretz, Frank
dc.contributor.authorMöllenhoff, Kathrin
dc.contributor.authorDette, Holger
dc.contributor.authorLiu, Wei
dc.contributor.authorTrampisch, Matthias
dc.date.accessioned2016-07-13T13:02:57Z
dc.date.available2016-07-13T13:02:57Z
dc.date.issued2016
dc.description.abstractWe 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.en
dc.identifier.urihttp://hdl.handle.net/2003/35138
dc.identifier.urihttp://dx.doi.org/10.17877/DE290R-17185
dc.language.isoende
dc.relation.ispartofseriesDiscussion Paper / SFB823;36, 2016en
dc.subjectequivalence testingen
dc.subjectsubgroup analysesen
dc.subjecttarget dose estimationen
dc.subjectmultiregional trialen
dc.subject.ddc310
dc.subject.ddc330
dc.subject.ddc620
dc.titleAssessing the similarity of dose response and target doses in two non-overlapping subgroupsen
dc.typeTextde
dc.type.publicationtypeworkingPaperde
dcterms.accessRightsopen access

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