GDUFA Research Outcomes
PBPK Models
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.
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Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation
Arora, Sumit; Patel, Nikunjkumar; Polak, Sebastian; Jamei; Roberts, Michael
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In Vitro-In Vivo Relationships (IVIVR) For Transdermal Delivery Of Nicotine From Patches
Alinaghi, Azadeh; Cheruvu, Hanumanth; Liu, Xin; Anissimov, Yuri; Kuswahyuning, Rina; Ghosh, Priyanka; Grice, Jeffrey; Raney, Sam; Roberts, Michael
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Does Vehicle Evaporation Affect Drug Distribution within Different Phases of Topically Applied Emulsion? A Modeling Case Study with Clindamycin Phosphate Lotion
Alam, Khondoker; Tsakalozou, Eleftheria; Babiskin, Andrew; Ghosh, Priyanka; Ramezanli, Tannaz; Jiang, Ying; Niu, Mengmeng; Zhao, Liang
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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