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.

• All(374)
• Posters(145)
• Presentations(185)
• Papers(44)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Is Water Activity The Primary Determinant Of Metamorphosis For Topical Creams?

  Srinatha, A; Ghosh, P; Raney, S G; Maibach, H I; Murthy, S N

• 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

• Clinical Relevance Of Rheological Characteristics Of Topical Creams: Relationship Between Yield Stress And Dose Spreading Area

  Srinatha, A; Hashemnejad, S M; Kundu, S; Ghosh, P; Raney, S G; Murthy, S N