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Pharmacy / Generic drug / Abbreviated New Drug Application / Bioequivalence / Physiologically based pharmacokinetic modelling / Food and Drug Administration / Pharmacodynamics / In vivo / Methylphenidate / Pharmaceutical sciences / Pharmacology / Pharmacokinetics


FY 2014 Awarded GDUFA Regulatory Research Contracts and Grants Characterization of Epilepsy Patients at Risk for Adverse Outcomes Related to Switching Antiepileptic Drug Products • Awarded to the University of Maryland
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City

Baltimore / Physiologically / /

Company

ZoneOne Pharma Inc. / Simulations Plus Inc. / Akina Inc. / Vince & Associates Clinical Research Inc. / CFD Research Corporation / Applied Research Associates Inc. / Simcyp Ltd. / /

Facility

Texas A&M University / Virginia Commonwealth University / Massachusetts General Hospital / University of Connecticut / University of Eastern Finland / University of Utah / G Ronzoni Institute / The University / Auburn University / State University of New York / Women’s Hospital / University of Florida / University of South Australia / University of Mississippi / University of Maryland / Massachusetts Institute of Technology / Johns Hopkins University / Purdue University / University of California / University of Massachusetts Lowell / /

IndustryTerm

generic heparin products / final drug product / simulation tools / supply chain / dispersion drug products / generic metoprolol products / drug product / sodium products / manufacturing parameters / metoprolol products / semisolid topical drug products / topical drug product / measurable physical/chemical qualities / teh heparin supply chain / ocular suspension drug products / iron complex products / pharmaceutical development tool / computational tools / sustained release products / active pharmaceutical ingredient purification process / manufacturing processes / product manufacturing / orally-inhaled drug products / manufacturing process variables / integrated pharmaceutical manufacturing processes / generic iron complex products / dermal products / semisolid ocular drug products / generic ocular semisolid drug products / manufacturing differences / emulsion drug products / computational tool / generic liposomal drug products / generic topical drug products / pharmaceutical induction port assembly / release products / pharmaceutical products / software program / parenteral sustained release products / generic ocular drug products / generic drug products / drug products / generic products / /

MedicalCondition

rheumatoid arthritis / pediatric attention deficit hyperactivity disorder / generic pulmonary drug development / pulmonary drug delivery / TBI / diseases / epilepsy / /

Organization

Rutgers / University of South Australia / Auburn University / University of Maryland / University of Connecticut / Virginia Commonwealth University / Women’s Hospital / Johns Hopkins University / Massachusetts General Hospital / Massachusetts Institute of Technology / Ronzoni Institute for Chemical and Biochemical Research / Purdue University / University of Mississippi / University of Utah / State University of New York at Buffalo / FDA / University of California / Los Angeles / Texas A&M University / office of Generic Drugs / University of Florida / University of Massachusetts Lowell / University of California / San Diego / /

Product

cyclosporine / tobramycin / amphotericin B / warfarin sodium / methylphenidate hydrochloride / /

ProvinceOrState

Maryland / Connecticut / South Australia / Utah / Mississippi / Florida / California / Massachusetts / /

Region

South Australia / Eastern Finland / /

Technology

fluid dynamics / pharmacokinetics / drug delivery / pharmacodynamics / Simulation / drug development / /

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