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)

• Feasibility of In Vitro Permeation Testing for Cleocin T® (Clindamycin Phosphate) Topical Lotion to Support a Demonstration of Bioequivalence

  Bolla, Pradeep; Hamad, Ghaled; Jiang, Ying; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam; Ashraf, Muhammad; Zidan, Ahmed

• Dermal OFM Indicates Differences in Acyclovir Skin Penetration between Males and Females

  Bodenlenz, Manfred; Augustin, Thomas; Birngruber, Thomas; Tiffner, Katrin; Raml, Reingard; Sinner, Frank

• Variability of Topical Penetration Data: What do we Learn from a Be-study using Dermal Open Flow Microperfusion

  Bodenlenz, Manfred; Augustin, Thomas; Birngruber, Thomas; Tiffner, Katrin; Raml, Reingard; Raney, Sam; Sinner, Frank

• In Vivo Dermal Open Flow Microperfusion: Understanding and Controlling Sources of Variability to Evaluate Topical Bioequivalence

  Bodenlenz, M; Birngruber, T; Tiffner, K; Raml, R; Tschapeller, B; Augustin, T; Schwagerle, G; Korsatko, S; Kanfer, I; Raney, S G; Sinner, F

• Validation of an In Vitro Release Test (IVRT) for Acyclovir Creams Including Apparatus and Laboratory Qualification

  Birngruber, T; Tiffner, K; Kanfer, I; Schimek, D; Reisenegger, P; Raml, R; Augustin, T; Sinner, F

• Dermal Open Flow Microperfusion as a Pharmacokinetic Approach to Evaluate Bioequivalence for Topical Drug Products

  Birngruber, T; Bodenlenz, M; Tiffner, K; Raml, R; Tschapeller, B; Augustin, T; Dragatin, C; Schimek, D; Schwagerle, G; Korsatko, S; Kanfer, I; Sinner, F

• Characterization of Topical Products and Their Fate Post-application with Label-free Chemical Imaging

  Belsey, N A; Tsikritsis, D; Zarmpi, P; Tyagi, V; Maciel-Tabosa, A; Vorng, J-L; Dexter, A; Delgado-Charro, M B; Guy, R H

• Integrating Drug Product Quality Attributes in a Bottom-Up Physiologically Based Pharmacokinetic (PBPK) Model to Simulate In Vitro Skin Permeation of Acyclovir Commercial Formulations

  Arora, Sumit; Polak, Sebastian; Jamei, Masoud; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Liu, Xin; Namjoshi, Sarika; Grice, Jeffrey; Mohammed, Yousuf; Roberts, Michael

• Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation

  Arora, S; Patel, N; Polak, S; Jamei, M; Tsakalozou, E; Ghosh, P; Alam, K; Liu, X; Namjoshi, S; Grice, J; Mohammed, Y; Roberts, M

• Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation

  Arora, Sumit; Patel, Nikunjkumar; Polak, Sebastian; Jamei; Roberts, Michael