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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Facilitating Drug Development Through GDUFA Regulatory Science and Research Opportunities for Collaboration with FDA
Ghosh, Priyanka; Ramezanli, Tannaz; Luke, Markham
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Open Flow Microperfusion As A Dermal Pharmacokinetic Approach To Evaluate Topical Bioequivalence
Bodenlenz, M; Tiffner, K; Raml, R; Tschapeller, B; Augustin, T; Dragatin, C; Birngruber, T; Kainz, S; Schwagerle, G; Korsatko, S; Raney, S; Sinner, F
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Evaluation of Metronidazole Bioavailability from Dermal Products Using an In Vitro Permeation Test (IVPT) Across Human Skin
Zhang, Qingzhao; Ghosh, Priyanka; Rantou, Elena; Raney, Sam; Hammell, Dana; Stinchcomb, Audra
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Evaluation of Metronidazole Bioavailability from Dermal Products Using an In Vitro Permeation Test (IVPT) Across Human Skin
Zhang, Qingzhao; Ghosh, Priyanka; Rantou, Elena; Raney, Sam; Hammell, Dana; Stinchcomb, Audra
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Assessment of Bioavailability of Rivastigmine from Two Rivastigmine Transdermal Delivery Systems with and without Exposure to Heat Using In Vitro Permeation Test (IVPT)
Zhang, Qingzhao; Ghosh, Priyanka; Raney, Sam; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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Characterization of the Cutaneous Pharmacokinetics of Three Metronidazole Topical Drug Products Evaluated by an In Vitro Permeation Test (IVPT) with Excised Human Skin
Zhang, Qingzhao; Ghosh, Priyanka; Raney, Sam; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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Characterization of the Cutaneous Pharmacokinetics of Three Metronidazole Topical Drug Products Evaluated by an In Vitro Permeation Test (IVPT) with Excised Human Skin
Zhang, Qingzhao; Ghosh, Priyanka; Raney, Sam; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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Confocal Raman Spectroscopic Assessment of the Topical Bioavailability of Metronidazole: Comparison of Laboratory-Made Formulations and Approved Drug Products
Zarmpi, P; Tsikritsis, D; Watson, A; Vorng, J-L; Tyagi, V; Ghosh, P; Belsey, NA; Woodman, T J; White, KAJ; Bunge, AL; Delgado-Charro, MB; Guy, RH
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Confocal Raman Spectroscopic Assessment of the Topical Bioavailability of Metronidazole: Comparison of Laboratory-Made Formulations and Approved Drug Products
Zarmpi, P; Tsikritsis, D; Watson, A; Vorng, J L; Tyagi, V; Ghosh, P; Belsey, N A; Woodman, T J; White, KAJ; Bunge, AL; Delgado-Charro, M B; Guy, R H
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Assessing Dermatological Product Bioequivalence With Raman Spectroscopy
Zarmpi, P; Maciel-Tabosa, A; Vitry, P; Tsikritsis, D; Belsey, N; Vorng, J L; Woodman, T J; Bunge, A L; White, K A J; Delgado-Charro, M B; Guy, R H