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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In Vitro Permeation Test (IVPT) Fundamentals: Scientific and Practical Considerations
Raney, Sam
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Statistical Considerations in Assessing BE of IVPT Data
Rantou, Elena
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Precilinical Models for Pulmonary Delivery
Hochhaus, Guenther
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New developments in the Assessment of Cutaneous Bioavailability and Bioequivalence of Topical Dermatological Drug Products Using Dermal Microdialysis
Senemar, Sharareh
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Mathematical Models of Skin Penetration
Heisig, Michael; Nagel, Arne; Wittum, Gabriel
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Parameter Sensitivity Analysis of a Two-Dimensional Skin Diffusion Model
Heisig, Michael; Nagel, Arne; Wittum, Gabriel
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Mathematical Models of Skin Penetration
Heisig, Michael; Nagel, Arne; Wittum, Gabriel
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Drug Permeation through Skin: A Challenging Application for High Performance Scientific Computing
Heisig, M; Nagel, A; Wittum, G
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Use of Skin Pharmacokinetics (PK) & Pharmacodynamics (PD) in Drug Development
Sinner, Frank
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Dermatopharmacokinetics: Modelling, Assessment and Optimization
Guy, Richard