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Abstract Details
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Activity Number:
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177
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301767 |
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Title:
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A Dose-Finding Method in Joint Modeling for Mixed Type of Efficacy and Safety Outcomes
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Author(s):
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Aiyang Tao*+ and Yong Lin and Jose Carlos Pinheiro and Weichung Joe Shih
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Companies:
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Novartis and University of Medicine and Dentistry of New Jersey and Johnson & Johnson Pharmaceutical R&D, LLC and University of Medicine and Dentistry of New Jersey
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Address:
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75 westview rd, Short Hills, NJ, 07078, USA
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Keywords:
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dose-finding ;
joint model ;
mixed outcomes
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Abstract:
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Determination of appropriate dose(s) to advance into Phase III is one of the most challenging and important decisions made during drug development. In clinical trials there are numerous cases that continuous and discrete endpoints are observed.It is very common that we need to consider joint continuous and discrete responses for the dose finding. This paper will address how to select dose(s) in Phase II trials by combining information about the efficacy and safety in a joint model setting for mixed type of outcomes. The methods we present in the paper may play a key role in drug development program and are often the gate-keeper for large confirmatory Phase III trials with greater chance for success of approval.
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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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