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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

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

  Zhao, Liang

• 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

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

  Alam, Khondoker

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

  Arora, Sumit

• Influence of Metamorphosis on the Performance of Topical Formulations

  Ajjarapu, Srinivas

• Impact of Fractional Solubility on Drug Permeation from Topical Formulations

  Ajjarapu, Srinivas

• Sensory Panel Tests for Topical Semi-Solid Gels: Role of Critical Quality Attributes in Predicting Sensorial Perceptions

  Phan, Khanh; Leite-Silva, Vania R; Prakash, Sangeeta; Liu, David; Namjoshi, Sarika; Panchal, Bhavesh; Ramezanli, Tannaz; Ghosh, Priyanka; Natarajan, Karthika; Raney, Sam G; Luke, Markham; Roberts, Michael; Mohammed, Yousuf

• Assessment of Bio(in)equivalence of Metronidazole Topical Formulation using Stimulated Raman Scattering Microscopy

  Zarmpi, P; Tsikritsis, D; Watson, A; Vorng, J L; Tyagi, V; Ghosh, P; Belsey, N; Woodman, T J; Jane White, KA; Bunge, A L; Delgado-Charro, M; Guy, R H

• Impact of Quantitative Differences in an Inactive Ingredient on the Performance of Topical Products Containing Lidocaine or Diclofenac Sodium

  Rangappa, S; Ghosh, P; Jiang, Y; Raney, S.G.; Narasimha Murthy, S

• A Clinical Study to Assess the Bioequivalence of Topical Diclofenac Products Using Dermal Open Flow Microperfusion

  Tiffner, Katrin; Ramezanli, Tannaz; Birngruber, Thomas; Bodenlenz, Manfred; Teles, Felipe; Raml, Reingard; Kainz, Sonja; Raney, Sam G; Sinner, Frank