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 Heat Effects on Fentanyl Transdermal Delivery Systems Using In Vitro Permeation and In Vitro Release Methods
Zhang, Qian; Murawsky, Michael; Lacount, Terri; Hao, Jinsong; Ghosh, Priyanka; Raney, Sam; Kasting, Gerald; Li, Kevin
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Generic Drug Device Combination Products: Regulatory and Scientific Considerations
Choi, Stephanie; Wang, Yan; Conti, Denise; Raney, Sam; Delvadia, Renishkumar; Leboeuf, Andrew; Witzmann, Kimberly
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A New Paradigm for Topical Generic Drug Products: Impact on Therapeutic Access
Luke, Markham
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Transepidermal Water Loss and Skin Conductance as Barrier Integrity Tests
Zhang, Qian; Murawsky, Michael; Lacount, Terri; Kasting, Gerald; Li, Kevin
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Evaluation of In Vitro/In Vivo Correlations for Three Fentanyl Transdermal Delivery Systems Using In Vitro Skin Permeation Testing and Human Pharmacokinetic Studies under the Influence of Transient Heat Application
Shin, Soo Hyeon; Yu, Mingming; Hammell, Dana; Ghosh, Priyanka; Raney, Sam; Hassan, Hazem; Stinchcomb, Audra
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Evaluation of heat effects on transdermal nicotine delivery in vitro and in silico using heat-enhanced transport model analysis
La Count, Terri; Zhang, Qian; Murawsky, Michael; Hao, Jinsong; Ghosh, Priyanka; Dave, Kaushalkumar; Raney, Sam; Talattof, Arjang; Kasting, Gerald; Li, Kevin
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A Fully Validated LC-MSMS Method for Simultaneous Determination of Nicotine its Metabolite Cotinine in Human Serum its Application to a Pharmacokinetic Study after Using Nicotine Transdermal Delivery Systems with Stard Heat Application in Adult Smokers
Abdallaha, Inas; Hammell, Dana; Stinchcomb, Audra; Hassan, Hazem
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Identification of Non-Reported Bupropion Metabolites in Human Plasma
Connarn, Jamie; Luo, Ruijuan; Windak, Jim; Zhang, Xinyuan; Babiskin, Andrew; Kelly, Marisa; Harrington, Gloria; Ellingrod, Vicki; Kamali, Masoud; Mcinnis, Melvin; Sun, Duxin
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Modeling Temperature-Dependent Dermal Absorption and Clearance for Transdermal and Topical Drug Applications
Lacount, Terri; Zhang, Qian; Hao, Jinsong; Ghosh, Priyanka; Raney, Sam; Talattof, Arjang; Kasting, Gerald; Li, Kevin
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Identification of critical formulation parameters affecting the in vitro release, permeation, and rheological properties of the acyclovir topical cream
Kamal, Nahid; Krishnaiah, Yellela; Xu, Xiaoming; Zidan, Ahmed; Raney, Sam; Cruz, Celia; Ashraf, Muhammad