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.
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Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 2
Arora, Sumit
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Research Overview and Regulatory Experience on Mechanistic Modeling for Generic Dermatological Drug Products
Alam, Khondoker
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Influence of Metamorphosis on the Performance of Topical Formulations
Ajjarapu, Srinivas
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Impact of Fractional Solubility on Drug Permeation from Topical Formulations
Ajjarapu, Srinivas
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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