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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Estimating Maximal In Vitro Skin Permeation Flux from Studies Using Non-Sink Receptor Phase Conditions
Yousef, Shereen; Liu, Xin; Mostafa, Ahmed; Mohammed, Yousuf; Grice, Jeffrey; Anissimov, Yuri; Sakran, Wedad; Roberts, Michael
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A Compartment-Quasi-3D Multiscale Approach for Drug Absorption, Transport, and Retention in the Human Lungs
Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej
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Validating Whole-Airway CFD Predictions of DPI Aerosol Deposition at Multiple Flow Rates
Longest, Worth; Tian, Geng; Khajeh Hosseini Dalasm, Nawab; Hindle, Michael
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In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
Walenga, Ross; Babiskin, Andrew; Zhao, Liang
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Importance of Spray-Wall Interaction and Post-Deposition Liquid Motion in the Transport and Delivery of Pharmaceutical Nasal Sprays
Kolanjiyil, Arun V; Alfaifi, Ali; Aladwani, Ghali; Golshahi, Laleh; Longest, Worth
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Topical Drug Delivery: History, Percutaneous Absorption, and Product Development
Roberts, Michael; Cheruvu, Manumanth; Mangion, Sean; Alinaghi, Azadeh; Benson, Heather; Mohammed, Yousef; Holmes, Amy; Van Der Hoek, John; Pastore, Michael; Grice, Jeffrey
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Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model
Arora, Sumit; Clarke, James; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Grice, Jeffery E; Roberts, Michael S; Jamei, Masoud; Polak, Sebastian
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Mechanistic Modeling of Generic Orally Inhaled Drug Products: A Workshop Summary Report
Walenga, Ross; Butler, Clare; Craven, Brent; Longest, P Worth; Mohamed, Raja; Newman, Bryan; Olsson, Bo; Hochhaus, Gunther; Li, Bing; Luke, Markham; Zhao, Liang; Przekwas, Andrzej; Lionberge, Robert
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Mechanistic Evaluation of Hydration Effects on the Human Epidermal Permeation of Salicylate Esters
Yousef, Shereen; Mohammed, Yousuf; Namjoshi, Sarika; Grice, Jeffrey; Sakran, Wedad; Roberts, Michael
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Research and Education Needs for Complex Generics
Stern, Sydney; Coghlin, Jill; Krishnan, Vishalakshi; Raney, Sam G; Babiskin, Andrew; Jiang, Wenlei; Lionberger, Robert; Xu, Xiaoming; Schwendeman, Anna; Polli, James E.