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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Estimation of In Vivo Skin Permeation (Flux) and Cumulative Amount Input of Metronidazole Formulations in Mini-Pigs’ Dermis
Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia
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Estimation of In Vivo Skin Permeation (Flux) and Cumulative Amount Input of Metronidazole Formulations in Mini-Pigs’ Dermis
Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia
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Effect of Formulation Wipe-Off Time on Topical Bioavailability of Metronidazole Using Dermal Microdialysis
Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia
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LC/MS/MS Method for the Quantification of Metronidazole in Skin Dialysate
Kuzma, Benjamin; Senemar, Sharareh; DePinto, Richard; Stagni, Grazia
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Evaluation of Local Bioavailability of Metronidazole from Topical Formulations Using Dermal Microdialysis: Preliminary Studies in Yucatan Mini-Pig
Kuzma, Benjamin; Senemar, Sharareh; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam; Stagni, Grazia
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Developing Efficient Bioequivalence Approaches for Generic Vaginal Drug Products
Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam G.
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Strategic analysis of the Roadmap for Implementing Characterization-Based Bioequivalence Approaches in Product-Specific Guidances for Generic Topical Dermatological Drug Products
Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam
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Strategic analysis of the Roadmap for Implementing Characterization-Based Bioequivalence Approaches in Product-Specific Guidances for Generic Topical Dermatological Drug Products
Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam
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Visualizing the Penetration of Semisolid Topical Formulations in Excised Human Skin by non-Invasive Confocal Raman Microscopy
Jung, Nathalie; Namjoshi, Sarika; Mohammed, Yousuf; Grice, Jeffrey; Raney, Sam; Roberts, Michael; Windbergs, Maike
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Evaluation of Penetration Kinetics of Commercial Topical Formulations in Human Skin using Non-invasive Confocal Raman Microscopy
Jung, Nathalie; Namjoshi, Sarika; Mohammed, Yousuf; Grice, Jeffrey; Raney, Sam; Roberts, Michael; Windbergs, Maike