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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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
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FDA and Dermatology – Topical Drug Products: New Paradigm for Generics
Luke, Markham
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General Considerations for the “No Significant Difference” Evaluation of a Proposed Generic Formulation
Kelchen, Megan
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The Development And Application Of Surrogate Methods To Assess Bioequivalence Of Topical Generic Products Intended For Local Action
Kanfer,Isadore
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Role of Excipients in Dermal and Transdermal Delivery of Drugs
Murthy, Narasimha