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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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, Sameersingh; 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, Sameersingh; 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, Sameersingh; 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, Sameersingh; Roberts, Michael
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Water Content and Product Drying Rate as Well as the Amount of Propylene Glycol May Impact the Topical Bioavailability of Acyclovir from Cream Products
Mohammed, Yousuf; Namjoshi, Sarika; Benson, Heather; Grice, Jeffrey; Raney, Sameersingh; Roberts, Michael
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Are Topical Products Dispensed from Different Packaging Q3 Equivalent and Bioequivalent?
Mohammed, Yousuf; Namjoshi, Sarika; Jung, Nathalie; Shewan, Heather; Stokes, Jason; Benson, Heather; Grice, Jeffrey; Windbergs, Maike; Raney, Sameersingh; Roberts, Michael