GDUFA Research Outcomes
Transdermal Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the transdermal route, including transdermal delivery systems.
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Strategic analysis of the Roadmap for Implementing Characterization-Based Bioequivalence Approaches in Product-Specific Guidances for Generic Topical Dermatological Drug Products
Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam
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Preparation, Characterization and In Vitro Release Test (IVRT) Study of Tretinoin-Loaded Microspheres in a Topical Gel Product
Hamad, Ghaled; Niu, Mengmeng; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam; Ashraf, Muhammad; Zidan, Ahmed
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LC-MS/MS Determination of Nicotine and its Metabolite Cotinine in Human Plasma
Abdallaha, Inas; Ghosh, Priyanka; Newman, Bryan; Raney, Sam; Stinchcomb, Audra; Hassan, Hazem
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Preformulation Analysis And Product Stability Of Norelgestromin/Ethinyl Estradiol Intravenous Infusion
Abdallah, Inas; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra