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Activity Number:
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430
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303930 |
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Title:
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Simulation Modeling Approaches: Applications for Analysis and Design of Islet Cell Transplant Clinical Trials
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Author(s):
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Maithili Daphtary*+ and Hong Yang and Bruce S. Schneider and Jawahar Tiwari and Steven A. Anderson
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Companies:
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FDA and FDA and FDA and FDA and FDA
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Address:
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1401 Rockville Pike HFM 219, Rockville, MD, 20852,
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Keywords:
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clinical trial simulation ; clinical trials ; islet cell transplant ; diabetes ; risk
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Abstract:
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In silico simulation of pancreatic islet cell transplant clinical trials in metabolically unstable Type 1 diabetics is performed based on data from studies of over 300 islet transplant recipients. We have developed a novel approach that uses both standard statistical methods and multistate models including flowgraph and compartmental models to simulate clinical outcomes and evaluate the efficacy of islet transplants. The models incorporate several factors, including time between treatment response and recurrence of hypoglycemia or islet failure, as transplant recipients progress through different clinical states. Residence times in clinically-important states are also predicted. The findings and conclusions in the abstract have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.
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