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Abstract Details
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Activity Number:
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13
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304027 |
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Title:
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Benefits of Model-Based Drug Development: A Rigorous Case Study
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Author(s):
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Russell Reeve*+
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Companies:
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Quintiles, Inc.
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Address:
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1102 Haywards Heath Lane, Apex, NC, 27502, United States
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Keywords:
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model-based drug development ;
case study ;
pharmacokinetic ;
dose-response ;
Bayesian ;
adaptive trial
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Abstract:
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Model-based drug development (MBDD) uses statistical models and computer-aided trial design technologies to improve the probability of successful drug development decisions. The primary goals of MBDD are the identification of a drug's safe and effective dosing regimen by use of efficient trial designs, programs, and portfolios. Advocates within regulatory agencies, drug development organizations, and academia recommend using MBDD to help facilitate the drug development decision process. While prior case studies demonstrate MBDD is effective in improving drug development, this case study adds to the literature compilation by presenting a comparison of the actual prospective program results, obtained without using MBDD methodologies, with a simulated retrospective MBDD driven program. At each stage of the simulated MBDD program, data is analyzed and predictions are constructed for the next
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Authors who are presenting talks have a * after their name.
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