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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Physiologically-based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%
Tsakalozou, Eleftheria; Babiskin, Andrew; Zhao, Liang
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Scientific and Regulatory Activities Initiated by the U.S. Food and Drug Administration to Foster Approvals of Generic Dry Powder Inhalers: Bioequivalence Perspective
Newman, Bryan; Babiskin, Andrew; Bielski, Elizabeth; Boc, Susan; Dhapare, Sneha; Fang, Lanyan; Feibus, Karen; Kaviratna, Anubhav; Li, Bing V; Luke, Markham; Ma, Tian; Walenga, Ross; Wang, Zhong; Zhao, Liang; El-Gendy, Nashwa; Bertha, Craig; El-Shafy, Mohammed; Gaglani, Dhaval
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A Multiscale Physiologically-Based Pharmacokinetic Model for Doxorubicin to Explore its Mechanisms of Cytotoxicity and Cardiotoxicity in Human Physiological Contexts
He, Hua; Liu, Can; Wu, Yun; Zhang, Xinyuan; Fan, Jianghong; Cao, Yanguang
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Mathematical Modeling of the Heterogeneous Distributions of Nanomedicines in Solid Tumors
He, Hua; Liu, Can; Liu, Yuhui; Liu, Xiaoquan; Wu, Yun; Fan, Jianghong; Zhao, Liang; Cao, Yanguang
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Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time
Walenga, Ross; Babiskin, Andrew; Zhang, Xinyuan; Absar, Mohammad; Zhao, Liang; Lionberger, Robert
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Prediction of In Vitro Drug Dissolution into Fed-state Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity
Polli, James E.
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Effects of Dose Loading Conditions and Device Geometry on the Transport and a Aerosolization in Dry Powder Inhalers: A Simulation Study
Sulaiman, Mostafa; Liu, Xiaoyu; Sundaresan, Sankaran
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Comparing MDI and DPI Aerosol Deposition Using In Vitro Experiments and a New Stochastic Individual Path (SIP) Model of the Conducting Airways
Longest, Worth; Tian, Geng; Walenga, Ross; Hindle, Michael
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Diffusion Modelling of Percutaneous Absorption Kinetics. Predicting Urinary Excretion from In Vitro Skin Permeation Tests (IVPT) for an Infinite Dose
Liu, Xin; Yousef, Shereen; Anissimov, Yuri; Van Der Hoek, John; Hoek, John; Tsakalozou, Eleftheria; Ni, Zhanglin; Grice, Jeffrey; Roberts, Michael
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Validating CFD Predictions of Pharmaceutical Aerosol Deposition with In Vivo Data
Tian, Geng; Hindle, Michael; Lee, Sau; Longest, Worth