Abstract Details
Activity Number:
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30
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Type:
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Contributed
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Date/Time:
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Sunday, August 3, 2014 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312533
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View Presentation
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Title:
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Adaptive Dose Finding Under Model Uncertainty Using MCP-Mod
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Author(s):
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Tobias Mielke*+
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Companies:
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Aptiv Solutions
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Keywords:
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Dose Finding ;
MCP-Mod ;
Adaptive designs ;
Optimal Designs
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Abstract:
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The determination of the optimal dose and the characterization of the dose-response relation are key objectives in drug development. Uncertainties on the underlying dose-response relation may result in inefficient and unsuccessful studies. Adaptive design and analysis methods may take these uncertainties into account in the planning stage. The MCP-Mod approach is an adaptive analysis method targeting the uncertainty on the dose-response model. A candidate set of dose response shapes is used to define a set of optimized trend tests. Based on the results of these trend tests, a subset of the candidate shapes is selected and fit to the data. The EMA draft qualification opinion on MCP-Mod states this approach as an efficient methodology for the design and analysis of dose-finding studies under model uncertainty. Adaptive designs additionally integrate updated information on the dose-response into optimized randomizations to dose-groups. After a short introduction on the MCP-Mod methodology, different adaptive dose-finding approaches will be presented. Limitations and benefits of standard and innovative dose-finding approaches will be discussed based on a practical simulation example.
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Authors who are presenting talks have a * after their name.
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