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Abstract Details

Activity Number: 246
Type: Contributed
Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305738
Title: Dose Proportionality Assessment Under Differing Alternating Panel Designs
Author(s): Deborah Panebianco*+ and Akira Wakana
Companies: Merck and MSD KK
Address: P.O. Box 1000, UG1D-44, North Wales, PA, 19454-1099, United States
Keywords: alternating-panel ; clinical trial ; dose proportionality

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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