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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Evaluation of Dermal Open Flow Microperfusion (dOFM) as a General Methodology to Assess the Bioequivalence of Hydrophobic, Protein-Bound Topical Drug Products
Tiffner, Katrin; Birngruber, Thomas; Schwagerle, Gerd; Bodenlenz, Manfred; Augustin, Thomas; Raml, Reingard; Kanfer, Isadore; Raney, Sam; Sinner, Frank
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Comparative In Vitro Release Of Six Different Topical Acyclovir Products Using A Vertical Diffusion Cell (VDC) Apparatus
Tiffner, K; Kanfer, I; Schimek, D; Reisenegger, P; Raml, R; Raney, S; Sinner, F
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Comparative In Vitro Release Tests (IVRT) of Seven Topical Acyclovir Products Using A Validated Ivrt Method With A Vertical Diffusion Cell (VDC) Apparatus
Tiffner, K; Kanfer, I; Schimek, D; Reisenegger, P; Raml, R; Augustin, T; Raney, S G; Sinner, F
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Comparative In Vitro Release Of Six Different Topical Acyclovir Products Using A Vertical Diffusion Cell (VDC) Apparatus
Tiffner, K; Kanfer, I; Schimek, D; Reisenegger, P; Raml, R; Raney, S G; Sinner, F
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Characterization of TEWL and Skin Impedance in a Clinical Study Measuring Acyclovir Permeation by Dermal Open Flow Microperfusion
Tiffner, Katrin; Bodenlenz, Manfred; Schwingenschuh, Simon; Hajnsek, Martin; Reisenegger, Peter; Kainz, Sonja; Augustin, Thomas; Baumann, Petra; Tschapeller, Bernd; Schwagerle, Gerd; Raml, Reingard; Kanfer, Isadore; Sinner, Frank
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Effect of Controlled Heat Application on Topical Diclofenac Formulations Evaluated by In Vitro Permeation Tests (Ivpt) using Porcine and Human Skin
Thomas, Sherin; Ghosh, Priyanka; Raney, Sam; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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Evaluating Influence Of Critical Quality Attributes Of Metronidazole Topical Gel On Bioequivalence Using The Dermal Virtual Bioequivalence (VBE) Module In Simcyp Simulator
Telaprolu, K C; Arora, S; Clarke, J; Dancik, Y; Tsakalozou, E; Ghosh, P; Alam, K; Roberts, M S; Polak, S
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Modeling In Vitro and In Vivo Human Skin Permeation of Eutectic Mixtures of Local Anesthetics Using PBPK Modeling: Development of Dermal IVIVE for Lidocaine 2.5% w/w and Prilocaine 2.5% w/w Cream (EMLA® Cream)
Telaprolu, K; Polak, S; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Dabbaghi, M; Namjoshi, S; Mohammed, Y; Grice, J; Roberts, M
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Is Water Activity The Primary Determinant Of Metamorphosis For Topical Creams?
Srinatha, A; Ghosh, P; Raney, S G; Maibach, H I; Murthy, S N
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Influence Of The Method Of Dose Application On The In Vitro Permeation Profile Of Acyclovir From Topical Creams
Srinatha, A; Maurya, A; Ghosh, P; Raney, S G; Murthy, S N