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dc.contributor.authorBretz, Franken_US
dc.contributor.authorDette, Holgeren_US
dc.contributor.authorPinheiro, Joséen_US
dc.description.abstractDetermining an adequate dose level for a drug and, more broadly, characterizing its dose response relationship, are key objectives in the clinical development of any medicinal drug. If the dose is set too high, safety and tolerability problems are likely to result, while selecting too low a dose makes it difficult to establish adequate efficacy in the confirmatory phase, possibly leading to a failed program. Hence, dose finding studies are of critical importance in drug development and need to be planned carefully. In this paper we focus on practical considerations for establishing efficient study designs to estimate target doses of interest. We consider optimal designs for both the estimation of the minimum effective dose (MED) and the dose achieving 100p% of the maximum treatment effect (EDp). These designs are compared with D-optimal designs for a given dose response model. Extensions to robust designs accounting for model uncertainty are also discussed. A case study is used to motivate and illustrate the methods from this paper.en_US
dc.publisher|aUniv., SFB 475|cDortmunden_US
dc.relation.ispartofseries|aTechnical Report // Sonderforschungsbereich 475, Komplexitätsreduktion in Multivariaten Datenstrukturen, Universität Dortmund|x2008,22en_US
dc.subject.keyworddose findingen_US
dc.subject.keywordrobust designsen_US
dc.subject.keywordmodel uncertaintyen_US
dc.subject.keywordminimum effective doseen_US
dc.subject.keyworddose responseen_US
dc.subject.keywordtarget dose estimationen_US
dc.subject.keywordsample sizeen_US
dc.titlePractical considerations for optimal designs in clinical dose finding studiesen_US
dc.type|aWorking Paperen_US

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