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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Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation
Le Merdy, Maxime; Alqaraghuli, Farah; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera
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In Vivo Predictive Dissolution: Transport Analysis of the CO2 , Bicarbonate in Vivo Buffer System
Krieg, Brian; Taghavi, Seyed; Amidon, Gordon; Amidon, Gregory
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Recent Developments in the Computational Simulation of Dry Powder Inhalers
Capecelatro, Jesse; Longest, Worth; Boerman, Connor; Sulaiman, Mostafa; Sundaresan, Sankaran
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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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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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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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Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development
Lemerdy, Maxime; Tan, Mingliang; Babiskin, Andrew; Zhao, Liang