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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Modeling of CNS Delivery for Nose-to-Brain Targeted Drug Products
Walenga, Ross
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Abbreviated New Drug Application (ANDA) and Pre-ANDA Experience with Orally Inhaled Drug Product (OIDP) Modeling
Walenga, Ross
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ANDA and Pre-ANDA Experience with OIDP Modeling
Walenga, Ross
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In Silico and Experimental Methods to Support Generic Nasal Drug Product (NDP) Development
Walenga, Ross
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Bridging the Gap Between Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation
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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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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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