Please use this identifier to cite or link to this item: https://hdl.handle.net/10419/36614 
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dc.contributor.authorBretz, Franken
dc.contributor.authorDette, Holgeren
dc.contributor.authorPinheiro, Joséen
dc.date.accessioned2009-05-26-
dc.date.accessioned2010-07-15T10:08:00Z-
dc.date.available2010-07-15T10:08:00Z-
dc.date.issued2008-
dc.identifier.urihttp://hdl.handle.net/10419/36614-
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
dc.language.isoengen
dc.publisher|aTechnische Universität Dortmund, Sonderforschungsbereich 475 - Komplexitätsreduktion in Multivariaten Datenstrukturen |cDortmunden
dc.relation.ispartofseries|aTechnical Report |x2008,22en
dc.subject.ddc519en
dc.subject.keyworddose findingen
dc.subject.keywordrobust designsen
dc.subject.keywordmodel uncertaintyen
dc.subject.keywordminimum effective doseen
dc.subject.keyworddose responseen
dc.subject.keywordtarget dose estimationen
dc.subject.keywordsample sizeen
dc.titlePractical considerations for optimal designs in clinical dose finding studies-
dc.typeWorking Paperen
dc.identifier.ppn600406350en
dc.rightshttp://www.econstor.eu/dspace/Nutzungsbedingungenen
dc.identifier.repecRePEc:zbw:sfb475:200822en

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