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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Role of Computational Fluid Dynamics and Physiologically-Based Pharmacokinetic Modeling in Development of Orally Inhaled and Nasal Drug Products
Walenga, Ross
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Credibility Establishment for Computational Fluid Dynamics Models of Complex Generic Drug Delivery
Walenga, Ross
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Computational Fluid Dynamics Modeling of Nasally Administered Drug Products in Regulatory Science Research at the U.S. Food and Drug Administration
Walenga, Ross
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Impact of Orally Inhaled and Nasal Drug Product PBPK Models on Product Development and Regulatory Decision Making
Walenga, Ross
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Role of Computational Fluid Dynamics and Physiologically-Based Pharmacokinetic Modeling in Development of Orally Inhaled and Nasal Drug Products
Walenga, Ross
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Computational Fluid Dynamics (CFD) Modeling for Product Development of Generic OINDPs and for Supporting Novel BE Approaches
Walenga, Ross
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In Silico QbD for Dermal Topical Formulations via TCAT Model Simulations
Spires, Jessica
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STATISTICAL EXPERIENCE AND CHALLENGES IN ASSESSING SIMILARITY OF DISSOLUTION PROFILES, PARTICAL SIZE DISTRIBUTIONS AND API SAMENESS
Tsong, Yi
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Enhanced Understanding of Structure Performance Relationship Using Modeling and Simulation – A Case Study with Dapsone Topical Gel
Tsakalozou, Eleftheria
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Are We Ready to Apply Oral PBPK Modeling for BE Determination?
Tsang, Yu Chung