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(452)
• Posters(198)
• Presentations(229)
• Papers(25)

• Improved Stratum Corneum Sampling In vivo Delivers Obvious Value for Topical Bioequivalence Assessment

  Bunge, A

• Dermal Open-Flow Microperfusion Indicates Differences in Topical Drug Permeation Between Males and Females

  Bodenlenz, M

• Correlation of Physicochemical Characteristics and in Vitro Permeation Test (IVPT) Results for Acyclovir Topical Products

  Zhao, Liang

• Visualization of Topical Drug Delivery with Label Free Chemical Imaging

  Belsey, Natalie

• Imaging Formulated Product Performance Using Optical Spectroscopy

  Belsey, Natalie

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

  Zhao, Liang (should be Arora S)

• 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

• 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