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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Predicting the Pharmacokinetics of Topically Applied Ketoprofen using Mechanistic Physiologically-based Pharmacokinetics Modelling
Abdulla, Tariq; Patel, Nikunjumar; Martins, Federico; Salem, Farzaneh; Clarke, James; Jamei, Masoud; Polak, Sebastian
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Quantitative Prediction of Dermal Drug Absorption using MPML-MechDermA model: Relative Effects of Application Site on Rivastigmine Pharmacokinetics from a Transdermal Delivery System
Abdulla, T; Patel, N; Polak, S; Martins, F; Rostami-Hodjegan, A; Jamei, M
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Relating Regional Variations in Skin Permeability to the Underlying Skin Morphology in Vivo
Abd, Eman; Mohammed, Yousef; Naegel, Arne; Grice, J; Wittum, Rebecca; Heisig, Michael; Wittum, Gabriel; Maibach, Howard; Roberts, Michael
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Relationships Between in Vivo Skin Permeability and Regional Variations in Morphological and Biophysical Skin Properties
Abd, E; Mohammed, Y; Naegel, A; Grice, J; Wittum, R; Heisig, M; Wittum, G; Maibach, H; Roberts, M