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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Deposition of Particles in the Alveolar Airways: Inhalation and Breath-Hold with Pharmaceutical Aerosols
Longest, Worth
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Well-Tempered MCMC Simulations for Population Pharmacokinetic Models
Bois, Frederic; Hsieh, Nan-Hung; Gao, Wang; Chiu, Weihsueh; Reisfeld, Brad
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Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products
Zhao, Liang; Seo, Paul; Lionberger, Robert
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Prediction of Food Effect on In Vitro Drug Dissolution into Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity
Polli, James E.
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Regulatory Science to Promote Access to Intrauterine Systems for Women in the United States
Sharan, Satish; Wang, Yan; Donnelly, Mark; Zou, Yuan; Fang, Lanyan; Kim, Myong Jin; Zhao, Liang
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Development of a CFD-PK Nasal Spray Model with In Vivo Human Subject Validation
Dutta, R; Kolanjiyil, AV; Golshahi, L; Longest, P
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Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development
Lemerdy, Maxime; Tan, Mingliang; Babiskin, Andrew; Zhao, Liang
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Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches: A Workshop Overview
Babiskin, Andrew; Wu, Fang; Mousa, Youssef; Tan, Ming-Liang; Tsakalozou, Eleftheria; Walenga, Ross; Yoon, Miyoung; Raney, Sam G; Polli, James E; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang
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Validating CFD Predictions of Highly Localized Aerosol Deposition in Airway Models: In Vitro Data and Effects of Surface Properties
Longest, Worth
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Effects of Subject-Variability on Nasally Inhaled Drug Deposition, Uptake, and Clearance
Chari, Sriram; Sridhar, Karthik; Kleinstreuer, Clement