CERSI P.I.s and Collaborators: Sarah Michel, Ph.D.; Maureen Kane, Ph.D.; Abraham Schneider, DDS, Ph.D.; Richard Dalby, Ph.D.
FDA SME and Collaborators: Vyomesh Patel, Ph.D., CTP
Project Overview
The goal of year 1 of the proposal is to develop a bioanalytical approach to identify the metal ions and HPHCs present in ECACs that are taken up by normal oral keratinocytes.Our bioanalytical strategy to measure the repertoire of EC hardware-derived metal ions and HPHCs present in ECACs and identify cellular uptake in oral keratinocytes will inform regulatory agencies charged with documenting the toxicological profile of new ECs prior to market authorization. We envision the FDA utilizing data from our assay and developed research tools to make regulatory decisions for both ECs in general and specific ECs (from different manufacturers). University of Maryland, Baltimore faculty contributing to the research are: Drs. Sarah Michel, Maureen Kane, Abraham Schneider, and Richard Dalby.
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