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Abstract Details
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Activity Number:
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113
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305056 |
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Title:
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Characterizing Dose-Response in the Development of Novel Treatments for Multiple Sclerosis
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Author(s):
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David I Ohlssen*+
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Companies:
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Novartis
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Address:
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One Health Plaza, East Hanover, NJ, , US
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Keywords:
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Multiple Sclerosis ;
Adaptive dose-finding designs ;
Generalized MCP-MOD ;
Negative binomial regression
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Abstract:
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This talk will discuss the design and analysis of dose-finding studies used in the development of drugs for multiple sclerosis. Following a brief introduction, providing some clinical background, we shall focus on two case-studies. The first, which was recently completed, involved a two cohort adaptive design. We shall provide an overview of the design and key results, along with a discussion of the key lessons learned. While in the second example, emphasis will be placed on assessing a number of design options for a new study, including: enrichment strategies; choice of end-point; and adaptive design. From a methods perspective, the talk will describe some extensions to the MCP-MOD approach, required to deal with over-dispersed count data.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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