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)

• Modeling Derma Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model

  Zhao, Liang

• Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model

  Zhao, Liang

• Integrating Topical Drug Product Quality Attributes Within Physiologically-based Pharmacokinetic Models

  Zhao, Liang

• Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model

  Zhao, Liang

• Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 2

  Arora, Sumit

• Research Overview and Regulatory Experience on Mechanistic Modeling for Generic Dermatological Drug Products

  Alam, Khondoker

• Influence of Metamorphosis on the Performance of Topical Formulations

  Ajjarapu, Srinivas

• Impact of Fractional Solubility on Drug Permeation from Topical Formulations

  Ajjarapu, Srinivas

• 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

• 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