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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A Quasi-3D Compartmental Multi-Scale Approach to Detect and Quantify Diseased Regional Lung Constriction Using Spirometry Data
Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej
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Generating Model Integrated Evidence for Generic Drug Development and Assessment
Zhao, Liang; Kim, Myongjin; Zhang, Lei; Lionberger, Robert
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A Mechanistic Bayesian Inferential Workflow for Estimation of In Vivo Skin Permeation from In Vitro Measurements
Hamadeh, Abdullah; Troutman, John; Najjar, Abdulkarim; Edginton, Andrea
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Mechanistic Modeling of Generic Orally Inhaled Drug Products (OIDPs): A Workshop Summary Report
Walenga, Ross; Butler, Clare; Craven, Brent A; Longest, Worth P; Mohamed, Raja; Newman, Bryan; Olsson, Bo; Hochhaus, Gunther; Hochhaus, Li, Bing V; Luke, Markham C; Zhao, Liang; Przekwas, Andrzej; Lionberger, Robert
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The Effects of Upper Airway Tissue Motion on Airflow Dynamics
Zhao, Yongling; Raco, Joel; Kourmatzis, Agisilaos; Diasinos, Sammy; Chan, Hak Kim; Yang, Runyu; Cheng, Shaokoon
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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; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang
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On the Importance of Liquid Motion in Nasal Spray Delivery
Kolanjiyil, AV; Golshahi, L; Longest, P
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The Influence of Secondary Processing on the Structural Relaxation Dynamics of Fluticasone Propionate
Depasquale, Roberto; Lee, Sau; Saluja, Bhawana; Shur, Jagdeep; Price, Robert
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Computational Analysis of a 3D Mucociliary Clearance Model Predicting Nasal Drug Uptake
Chari, Sriram; Sridhar, Karthik; Walenga, Ross; Kleinstreuer, Clement
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ASCPT 2019 Annual Meeting Pre-conference
Bai, Jane; Musante, Cynthia; Petanceska, Suzana; Zhang, Lei; Zhao, Liang; Zhao, Ping