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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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 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 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 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.
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Physiologically-based pharmacokinetic modeling to support determination of bioequivalence for dermatological drug products: scientific and regulatory considerations
Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Zhao, Liang
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Mechanistic Modeling of Drug Products Applied to the Skin: A Workshop Summary Report
Tsakalozou, Eleftheria; Alam, Khondoker; Ghosh, Priyanka; Spires, Jessica; Polak, Sebasitan; Fang, Lanyan; Sammeta, Srinivasa; Zhao, Ping; Arora, Sumit; Raney, Sam G
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In Silico Models of Aerosol Delivery to the Respiratory Tract – Development and Applications
Holbrook, Landon
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Effect of Spray Momentum on Nasal Spray Droplet Transport and Deposition
Kolanjiyil, Arun; Manniello, Michele; Alfaifi, Ali; Farkas, Dale; Hosseini, Sana; Hindle, Michael; Golshahi, Laleh; Longest, Worth
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Effect of an Upstream Grid on the Fluidization of Pharmaceutical Carrier Powders
Elserfy, Khalid; Kourmatzis, Agisilaos; Chan, Hak Kim; Walenga, Ross; Cheng, Shaokoon