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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Mechanistic Modelling Of Dermal Drug Absorption Using The Simcyp Multi-Phase Multi-Layer Mechderma Model: Case Study Of A Transdermal Patch Formulation Of Weak Base Drug Timolol
Patel, Nikunjkumar; Cristea, Sinziana; Rose, Rachel; Salem, Farzaneh; Abduljalil, Khaled; Johnson, Trevor; Jamei, Masoud; Raney, Sam; Zhang, Xinyuan; Lin, Hopi; Newman, Bryan; Chow, Edwin; Ghosh, Priyanka; Fan, Jianghong; Fang, Lanyan; Polak, Se
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In Vitro Assessment of Cooling Potential of the Topical Gel System and Influence of Inactive Ingredients
Panchal, Bhavesh; Namjoshi, Sarika; Ramezanli, Tannaz; Ghosh, Priyank; Raney, Sam G; Roberts, Michael; Mohammed, Yousuf
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Topical Semisolid Product Bioequivalence-A Case for Product Quality and Performance Assessment as Evaluation Tools
Namjoshi, S; Mohammed, Y; Telaprolu, K; Dabbaghi, M; Jung, N; Windbergs, M; Grice, J; Ramezanli, T; Raney, S; Roberts, M
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Microstructural Characterization of Microsponge-Based Gel Products Using CryoSEM
Mohammed, Yousef; Namjoshi, Sarika; Dabbaghi, Maryam; Ramezanli, Tannaz; Raney, Sam; Jiang, Ying; Grice, Jeffrey; Roberts, Michael
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Experimental Measurements and Mathematical Modelling of Volatile Loss from Binary Solvent Systems
Mohammed, Yousef; Namjoshi, Sarika; Silva, L; Dabbaghi, Maryam; Ramezanli, Tannaz; Raney, Sam; Grice, Jeffrey; Chen, Tao; Lian, Guoping; Roberts, Michael
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Scanning Electron Micrographic Structural Characterization of Microsponge Gel Products
Mohammed, Yousef; Namjoshi, Sarika; Dabbaghi, Maryam; Ramezanli, Tannaz; Raney, Sam; Grice, Jeffrey; Roberts, Michael
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Effects of Microstructure on Lidocaine-Prilocaine Topical Product Performance
Mohammed, Yousuf; Dabbaghi, Maryam; Namjoshi, Sarika; Telaprolu, Krishna; Rantou, Elena; Ramezanli, Tannaz; Raney, Sam; Grice, Jeffrey; Roberts, Michael
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The Impact of Topical Semisolid Product Microstructure and Metamorphosis on Bioavailability and Bioequivalence
Mohammed, Yousuf; Namjoshi, Sarika; Telaprolu, Krishna; Jung, Nathalie; Benson, Heather; Windbergs, Maike; Grice, Jeffrey; Raney, Sam; Roberts, Michael
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A Novel Method to Selectively Differentiate Between the Loss of Water and Other Volatiles from Topical Semisolid Products
Mohammed, Yousuf; Namjoshi, Sarika; Telaprolu, Krishna; Crowe, Arianna; Jung, Nathalie; Grice, Jeffrey; Windbergs, Maike; Benson, Heather; Raney, Sam; Roberts, Michael
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The Impact of Topical Semisolid Product Microstructure and Metamorphosis on Bioavailability and Bioequivalence
Mohammed, Yousuf; Namjoshi, Sarika; Jung, Nathalie; Telaprolu, Krishna; Grice, Jeffrey; Windbergs, Maike; Benson, Heather; Raney, Sam; Roberts, Michael