This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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569
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306379 |
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Title:
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Informed Decisionmaking Using Modeling and Simulation: Case Study of a Selective PDE5 Inhibitor for the Treatment of BPH
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Author(s):
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Patrick John Johnson*+
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Companies:
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Vifor Pharma Ltd.
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Address:
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Flughofstrasse 61, Glattbrugg, CH-8152, Switzerland
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Keywords:
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modeling ;
simulation
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Abstract:
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The use of M&S is recommended to improve the efficiency of clinical development and paramount to successful application is timely delivery of the right information. However, there is criticism that the expectation for M&S has not always been delivered. Enhanced quantitative drug development (EQDD) is a global initiative at Pfizer to promote the development of integrated analysis of available data (internal & external sources) and their application to inform strategy, trial design and decision-making in drug development (Lalonde et al, 2007). This quantitative approach was used in the development of UK369,003 for the treatment of BPH. This presentation will discuss how incorporating EQDD principles enabled M&S to be successfully implemented and delivered on time for a quantitative, clear and informed 'go/no go' Phase 3 decision.
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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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