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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Measuring Drug Concentration in the Skin in Vivo: Techniques and Challenges
Guy, Richard
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Predicting, Measuring, and Optimising Drug Delivery to the Skin
Guy, Richard
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Assessing Topical Drug Bioavailability in the Skin Using Raman Spectroscopy
Tabosa, Alice
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Bioequivalence of Generic Topical Dermatological Drug Products
Ghosh, Priyanka; Luke, Markham; Tsakalozou, Eleftheria; Simamora, Pahala
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Characterization Based Approaches for Establishing Bioequivalence Locally Acting Drug Products Applied to the Skin
Ghosh, Priyanka; Luke, Markham
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GDUFA Science and Research Collaborating with the FDA Research Program
Ghosh, Priyanka
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Visualizing and Quantifying Drugs Dermal Drug Development
Ghosh, Priyanka
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Product Development Considerations and Bioequivalence Strategies for Generic Topical Products
Ghosh, Priyanka
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Overview FDA’s Generic Drug Research Topical Dermatological Drug Products
Ghosh, Priyanka
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Scientific and Regulatory Considerations on Dermal PBPK Modeling for Virtual Bioequivalence Assessments and Decision-making
Tsakalozou, Eleftheria