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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Thoughts from a Regulatory Dermatologist
Luke, Markham
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Establishing Equivalence of TDS and OIDPs
Ghosh, Priyanka
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Role of Surface Morphological Characteristics of Substrate in Adhesion Performance of Topical and Transdermal Delivery Systems (TDS)
Phan, Khanh; Zhu, Jiexin; Ali, Masood, Ghosh, Priyanka; Jiang, Ying; Russo, Jackson; Luke, Markham C; Raney, Sam G; Mohammed, Yousuf
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Advances in Product Quality and Performance Tests for Topical and Transdermal Products: View of the USP Expert Panel
Raney, Sam; Senemar, Sharareh; Burke, Matt; Lee, Christina; Shah, Jaimin; Li, Kevin; Anand, O; Warner, Kevin
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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