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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In Vitro-In Vivo Correlations for Nicotine Transdermal Delivery Systems Evaluated by both In Vitro Skin Permeation (IVPT) and In Vivo Serum Pharmacokinetics under the Influence of Transient Heat Application
Shin, Soo Hyeon; Thomas, Sherin; Raney, Sam; Ghosh, Priyanka; Hammell, Dana; El Kamary, Samer; Chen, Wilbur; Billington, Melissa; Hassan, Hazem; Stinchcomb, Audra
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Determination of Rate and Extent of Scopolamine Release from Transderm Scop® Transdermal Drug Delivery Systems in Healthy Human Adults
Swaminathan, Suresh; Strasinger, Caroline; Kelchen, Megan; Carr, Jamie; Ye, Wei; Wokovich, Anna; Ghosh, Priyanka; Rajagopal, Srinivasan; Ueda, Kenichi; Fisher, James; Kandimalla, Karunya; Brogden, Nicole
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Norelgestromin/Ethinyl Estradiol Intravenous Infusion Formulationoptimization; Stability And Compatibility Testing: A Case Study To overcome Polysorbate 80 Interference In Chromatographic Analysis
Abdallaha, Inas; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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Characterization of Temperature Profiles in Skin Transdermal Delivery System When Exposed to Temperature Gradients In Vivo In Vitro
Zhang, Qian; Murawsky, Michael; Lacount, Terri; Hao, Jinsong; Kasting, Gerald; Newman, Bryan; Ghosh, Priyanka; Raney, Sam; Li, Kevin
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LC-MS Determination of Fentanyl in Human Serum and Application to a Fentanyl Transdermal Delivery Pharmacokinetic Study
Yu, Mingming; Abdallah, Inas; Shin, Soo Hyeon; Hammell, Dana; Stinchcomb, Audra; Hassan, Hazem
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Effect of Controlled Heat Application on Topical Diclofenac Formulations Evaluated by In Vitro Permeation Tests (Ivpt) using Porcine and Human Skin
Thomas, Sherin; Shin, Soo Hyeon; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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Heat Effects on Drug Delivery across Human Skin
Hao, Jinsong; Ghosh, Priyanka; Li, Kevin; Newman, Bryan; Kasting, Gerald; Raney, Sam
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Navigating Sticky Areas in Transdermal Product Development
Strasinger, Caroline; Raney, Sam; Tran, Doanh; Ghosh, Priyanka; Newman, Bryan; Bashaw, Edward; Ghosh, Tapash; Shukla, Chinmay
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On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl
Shin, Soo Hyeon; Ghosh, Priyanka; Newman, Bryan; Hammell, Dana; Raney, Sam; Hassan, Hazem; Stinchcomb, Audra
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Statistical Considerations and Impact of the FDA Draft Guidance for Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs
Sun, Wanjie; Grosser, Stella; Kim, Carol; Raney, Sam