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MiamiOH OARS on 08 May 13This project will investigate in vitro - in vivo correlations of transdermal systems. The project has several phases 1) Identification or generation of an in vivo data set of heat effects on transdermal products. The in vivo data set may be obtained from the literature or generated as a part of this grant. It may include identification of approved transdermal systems with in vivo heat effects on systemic exposure mentioned in the approved labeling. 2) Evaluation of these transdermal systems in a range of different in vitro test conditions to identify the in vitro conditions and study design that best identify the effect of heat on transdermal systems. These studies should be in-vitro skin flux permeation studies and include comparative in vitro release data at normal and elevated temperatures. 3) Evaluation of approved generic products with no in vivo heat effect data using the optimal in vitro conditions from phase 2.