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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Drug Compounding and the Dermatologist
Luke, Markham
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Developing Successful Topical Therapies for Dermatologic Disease
Luke, Markham
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Overcoming Barriers and Improving Patient Access to Topical Dermatological Drugs
Luke, Markham
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Novel Methodologies to Assess Cutaneous Bioavailability and Bioequivalence: Dermal Microdialysis and Coherent Raman Imaging
Kuzma, Benjamin
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Recent Advancements in Dermal Microdialysis to Assess Topical Bioavailability And Bioequivalence
Kuzma, Benjamin
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Topical Bioequivalence Update
Lionberger, Robert
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Topical Bioequivalence Update
Lionberger, Robert
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In-Vivo Flux: A Breakthrough in IVIVC of Topical Dermatological Formulations
Kuzma, Benjamin
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Estimation of in-Vivo Percutaneous Permeation (Flux) and Cumulative Amount Input of Metronidazole Formulations in Mini-Pigs’ Dermis
Kuzma, Benjamin
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Formulation Considerations for In Vitro Characterization Based Approaches of Locally Acting Complex Generic Drug Products
Kozak, Darby