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Activity Number:
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14
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 29, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308956 |
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Title:
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A Bayesian Design and Analysis for Dose-Response Using Informative Prior Information
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Author(s):
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Michael Smith*+ and Scott Marshall
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Companies:
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Pfizer Inc. and Pfizer Inc.
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Address:
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Ramsgate Rd, Sandwich, CT13 9NJ, United Kingdom
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Keywords:
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Dose-response ; Bayesian ; Emax model ; Informative priors ; relative potency ; proof of concept
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Abstract:
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We wish to use prior information on an existing drug in the design and analysis of a dose-response study for a new drug candidate within the same pharmacological class. Using Bayesian methodology this prior information can be used quantitatively and the randomization can be weighted in favor of the new compound, where there is less information. An Emax model is used to describe the dose-response of the existing drug. The estimates from this model are used to provide informative prior information used for the design and analysis of the new study to establish the relative potency between the new compound and the existing drug therapy. Simulations were performed to assess the operating characteristics of various designs and robustness to underlying assumptions.
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