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The scope of work is to perform applied regulatory research in ion channel pharmacology. The Trudeau lab will collaborate with the FDA as part of the Comprehensive in-vitro Proarrhythmia Assay (CiPA) initiative.


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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.


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This project focuses on patient prescriber agreements (PPAs) of prescription opioid analgesic drugs. In recent years, FDA has started to employ strategies to reduce misuse and abuse of opioid pain medications. PPAs are contracts between prescribers and their patients to at least list expectations of each the prescriber and the patient. With pain drugs a serious health issue, and opioids having abuse potential, there are several PPAs for various opioid pain medications.


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Ensuring readiness to evaluate innovative and emerging technologies is an important goal for the M-CERSI, focusing on new technologies that will contribute to the scientific underpinning of two device-related product areas: (1) laser-based therapeutic devices; and (2) tissue engineering constructs.


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"Improving pre-clinical assessments of safety and efficacy" focuses on membrane transporters in drug development. Membrane transporters allow nutrients to move throughout the body, and also move drugs throughout the body. However, these doorways can be the basis for drug-to-drug interactions, where a “perpetrator drug” interferes with how a second “victim drug” normally uses a transporter. The University of Maryland is conducting experiments in collaboration with FDA scientists in order to aid FDA to develop decision trees.


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This projects extends on-going work by Dr. James Polli to develop an in vitro dissolution test that predicts the absorption and pharmacokinetics of poorly soluble drugs that have been formulated via amorphous solid dispersion technology. In vitro dissolution is an important test of pharmaceutical quality. However, products of low solubility drugs that employ amorphous solid dispersion technology are complex. Results of these formulation and human pharmacokinetic studies aim to yield an in vitro test that others can rely upon.


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In this project, Dr. Bruce Yu is developing a simple and noninvasive technique to analyze sub-visible particulates in solutions. The method is based on the water proton NMR signal and can be carried out using desktop instruments without even taking the drug solution out of its vial. Sub-visible particulates formed by proteins is a safety concern for biologic products. Current analytics for such particulates are complex and invasive.


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A workgroup of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) is developing an Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) for the in vivo Pig-a gene mutation assay. The TG will foster regulatory acceptance of the assay for conducting safety assessments. 


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