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Abstract Details
Activity Number:
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246
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #305738 |
Title:
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Dose Proportionality Assessment Under Differing Alternating Panel Designs
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Author(s):
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Deborah Panebianco*+ and Akira Wakana
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Companies:
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Merck and MSD KK
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Address:
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P.O. Box 1000, UG1D-44, North Wales, PA, 19454-1099, United States
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Keywords:
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alternating-panel ;
clinical trial ;
dose proportionality
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Abstract:
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Alternating panel designs are frequently used to assess the safety, tolerability, and pharmacokinetics of a new investigational compound in the First in Human study. A typical design consists of two panels of eight subjects receiving single rising doses over four treatment periods. However, in some settings, we have begun using a leaner study design in which subjects in the two panels receive only two doses in two treatment periods. This research investigation compares the old and new designs with regard to their ability to characterize the dose proportionality of the compound. Two methods for assessing dose proportionality, the power law model (current approach) and equivalence of dose-normalized means, are applied to each design, using simulated data sets exhibiting varying degrees of non-dose-proportionality.
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