GDUFA Research Outcomes
Topical Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the topical route, including topical dermatological products.
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Stimulated Raman Scattering (SRS) Microscopy and Deep Learning: Novel Pharmacokinetic Approach for Evaluation of Topical Bioequivalence
Iliopoulos, Fotis; Pence, Isaac J; Ghosh, Priyanka; Raney, Sam G; Luke, Markham C; Evans, Conor L
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Solubility-Physicochemical-Thermodynamic Theory of Penetration Enhancer Mechanism of Action
Haq, Anika; Chandler, Mark; Michniak-Kohn, Bozena
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Evaluation of In Vitro Performance Attributes of Imvexxy® (Estradiol) Vaginal Insert
Hamad, Ghaled; Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam G; Ashraf, Muhammad; Zidan, Ahmed
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A Mechanistic Evaluation of Drug Availability from Imvexxy® (Estradiol) Vaginal Inserts
Hamad, Ghaled; Bolla, Pradeep; Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam; Ashraf, Muhammad; Zidan, Ahmed
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Interaction Studies of Tretinoin with Microspheres in Tretinoin Topical Gel
Hamad, Ghaled; Niu, Mengmeng; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam; Ashraf, Muhammad; Zidan, Ahmed
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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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Evaluation of U.S. FDA Approved Generic Oral Solution Products
Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei
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Tribological Response of Hydroxyethylcellulose Gels as a Function of Isopropyl Alcohol Concentration and Angular Velocity Profile
Dick, Arianna; Panchal, Bhavesh; Prakash, Sangeet; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam; Roberts, Michael; Mohammed, Yousuf
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Deciphering the Effects of Microstructure on Lidocaine-Prilocaine Topical Product Performance
Dabbaghi, M; Mohammed, Y; Namjoshi, S; K, Telaprolu; Rantou, E; Ramezanli, T; Raney, S; Roberts, M; Grice, J
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In Vitro-In Vivo Correlation (Ivivc) Of Diclofenac Bioavailability From Three Topical Drug Products
Cordery, Sarah; Chiu, Wingsin; Shehab, Zaher; Bunge, Annette; Delgado-Charro, Begona; Guy, Richard