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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Evaluation Of Bioavailability And In Vitro/In Vivo Correlation Of Nicotine Transdermal Drug Delivery Systems Under The Influence Of Heat
Shin, Soohyeon; Thomas, Sherin; Aballah, Inas; Raney, Sameersingh; Ghosh, Priyanka; Newman, Bryan; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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Influence of Heat on Reference and Generic Transdermal Drug Delivery Systems
Shin, Soohyeon; Ghosh, Priyanka; Newman, Bryan; Raney, Sameersingh; Hassan, Hazem; Stinchcomb, Audra
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Developing In Vitro-In Vivo Correlations (IVIVCs) for In Vitro Permeation Test and In Vivo Pharmacokinetic Studies to Evaluate the Effects of Heat on Nicotine Transdermal Delivery Systems
Ramezanli, Tannaz; Ghosh, Priyanka; Zhang, Yi; Luke, Markham; Shin, Soohyeon; Hassan, Hazem; Stinchcomb, Audra; Zhang, Qian; Raney, Sameersingh
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Skin Temperature Under Transdermal Patch With Heat Application. Poster Presentation
Murawsky, Michael; Zhang, Qinghua; LaCount, Terri; Hao, Jinsong; Newman, Bryan; Ghosh, Priyanka; Raney, Sameersingh; Kasting, Gerald; Li, Kevin
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An In Vitro Test Method for Evaluating the Effect of Heat on Tdds Performance
Murawsky, Michael; Zhang, Qinghua; LaCount, Terri; Hao, Jinsong; Newman, Bryan; Ghosh, Priyanka; Raney, Sameersingh; Kasting, Gerald; Li, Kevin
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Computational Model For Estimating The Effect Of Heat On Dermal Clearance In Skin Transport
LaCount, Terri; Li, Kevin; Kasting, Gerald
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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, Sameersingh
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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, Sameersingh
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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, Sameersingh; 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