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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Evaluating the Bioequivalence of Topical Dermatological Drug Products Containing Metronidazole Using Dermal Microdialysis: Preliminary Studies in Rabbits
Senemar, Sharareh; Kuzma, Benjamin; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sameersingh; Stagni, Grazia
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Evaluating the Bioequivalence of Topical Dermatological Drug Products Containing Metronidazole Using Dermal Microdialysis: Preliminary Studies in Rabbits
Senemar, Sharareh; Kuzma, Benjamin; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sameersingh; Stagni, G
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Influence of Varying Amount of an Inactive Ingredient on the Microstructure and Performance of Metronidazole Topical Gels
Rangappa, Srinath; Ghosh, Priyanka; Jiang, Ying; Raney, Sam G; Murthy, S Narasimha
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Comparative Evaluation of the Permeation of Metronidazole Using Static Diffusion Cells and Flow-Through Diffusion Cells
Rangappa, S; Ajjarapu, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Repka, M; Maibach, H; Narasimha Murthy, S
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Critical Quality Attributes of Topical Clobetasol Propionate Foams
Rangappa, S; Ajjarapu, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Repka, M; Maibach, H; Narasimha Murthy, S
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Critical Quality Attributes of Topical Pharmaceutical Foams
Rangappa, Srinath; Ajjarapu, Srinivas; Ghosh, Priyanka; Kelchen, Megan; Raney, Sameersingh; Repka, Michael; Maibach, Howard; Murthy, Narasimha
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Influence of Relative Humidity on Time to Break Analysis of Pharmaceutical Foams
Rangappa, Srinath; Ajjarapu, Srinivas; Ghosh, Priyanka; Kelchen, Megan; Raney, Sameersingh; Repka, Michael; Maibach, Howard; Murthy, Narasimha
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Comparative Assessment of the Physical and Structural Similarity of Topical Drug Products Containing Lidocaine and Prilocaine
Rangappa, Srinath; Ajjarapu, Srinivas; Varadarajan, Anandavalli; Prado, Rosa-Maria-Badani; Ghosh, Priyanka; Raney, Sameersingh; Kundu, Santanu; Repka, Michael; Murthy, Narasimha
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Evaluation of Bioavailability of Lidocaine and Prilocaine from Topical Drug Products Using an In Vitro Permeation Test (IVPT)
Rangappa, Srinath; Ajjarapu, Srinivas; Ghosh, Priyanka; Rantou, Elena; Raney, Sameersingh; Repka, Michael; Murthy, Narasimha
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Correlation between the Quality Attributes and Performance Characteristics of Metronidazole Gels and Creams: Implications for the Evaluation of Bioequivalence
Rangappa, Srinath; Ajjarapu, Srinivas; Hashemnejad, Seyed-Meysam; Prado, Rosa-Maria-Badani; Ghosh, Priyanka; Raney, Sameersingh; Kundu, Santanu; Murthy, Narasimha