CERSI P.I. and Collaborator: Audra Stinchconb, Ph.D., UMB
FDA SME and Collaborator: Caroline Strasinger, CDER FDA


Project Overview

Dr. Audra Stinchcomb is building on upon the currently FDA-funded project grant NIPTE-U01-MD-2015-001 titled, "Transdermal Drug Delivery Systems-Fentanyl" (program officer representative: Caroline Strasinger). This currently funded project is focused on human in vivo testing. The goal is to understand ways to label drug delivery rates from patches, as current dose labeling is not consistent among patch products. In vivo human studies employ fentanyl patches to determine delivery rates from pharmacokinetic parameters, as well as the residual drug amount left in the patch at the end of the wear time. This research team is creating a database of controlled human studies. In vitro studies are proposed here in order to assess if in vitro studies can mimic ongoing in vivo studies, in terms of delivery rates. In vitro studies would employ the same products that are being evaluated in vivo in humans. This correlation analysis will help develop in vitro tests to predict patch delivery rates.