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Abstract Details

Activity Number: 619
Type: Contributed
Date/Time: Thursday, August 2, 2012 : 8:30 AM to 10:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305591
Title: Preliminary Assessment of MCPMod for Dose-Response Modeling
Author(s): James Reynolds*+ and Joseph Gao
Companies: and Shire Development Inc.
Address: 581 Shakespeare Drive, Harleysville, PA, 19438-2167, United States
Keywords: Phase IIB ; Dose Response ; MCPMod ; minimum effective dose ; Clinical Trial Design
Abstract:

A phase IIb study was recently initiated to investigate the dose response of active treatment with regard to efficacy and safety. The study was designed and planned using the R function MCPMod in the DoseFinding package. The evaluation process which led to the adoption of this statistical methodology will be discussed. In addition, the manner in which the methodology will be implemented was chosen based on simulations. These simulations led to the choice of average Akaike Information Criterion for determining the minimum effective dose.

Bjorn Bornkamp, Jose Pinheiro and Frank Bretz (2011). DoseFinding: Planning and Analyzing Dose Finding experiments. R package version 0.5-3. http://CRAN.R-project.org/package=DoseFinding


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