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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Prediction, Assessment and Optimisation of Drug Delivery into and through the Skin
Guy, Richard
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Prediction and Optimization of Drug Delivery into and Through the Skin
Guy, Richard
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In-Vivo Skin PK Testing for New and Generic Topical Dermatological Drug Development
Sinner, Frank
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Clinical Pharmacokinetic Evaluation of Dermal Bioavailability and Bioequivalence
Sinner, Frank
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In Vivo Dermal Open Flow Microperfusion: A Novel Approach to Evaluating Topical Bioavailability and Bioequivalence
Sinner, Frank
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Innovative Dermal PK and PD: In Vivo Proof-of-Mechanism to Clinical Dermal Bioequivalence using Open Flow Microperfusion
Sinner, Frank
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Dermal Open Flow Microperfusion (Dofm) For The Bioequivalence Assessment Of Topical Products Based On Skin Pk
Sinner, Frank
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Evaluating Topical Bioavailability In Vivo By Dermal Open Flow Microperfusion And Equivalence By Ivrt
Sinner, Frank
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Tissue Specific Pk And Pd Enabled By Open Flow Microperfusion: From Bioequivalence To Mechanism Of Drug Action Poc Studies
Sinner, Frank
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In Vitro Bioequivalence Data for a Topical Product: Chemistry Review Perspective
Simamora, Pahala