GDUFA Research Outcomes
Nasal Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the nasal route, including nasal sprays.
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Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products
Walenga, Ross
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Modeling of CNS Delivery for Nose-to-Brain Targeted Drug Products
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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Credibility Establishment for Computational Fluid Dynamics Models of Complex Generic Drug Delivery
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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Advanced Characterization Approaches to Demonstrate Bioequivalence of Nasal Suspension Drug Products
Shur, Jag
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Pharmacokinetic Comparison of Locally Acting Nasal Suspension Spray Products
Hochhaus, Gunther; Bulitta, Jurgen
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Local and Systemic Absorption Predictions of Nasal Inhaled Corticosteroids: A Combined Approach
Schoroeter, Jeffry
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A CFD-PBPK Approach to Simulate Deposition, Absorption, and Bioavailability of Intranasal Corticosteroids
Schoroeter, Jeffry
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Prediction II: Computational Fluid Dynamics, as part of a workshop titled Bridging the Gap from Science to Clinical Efficacy: Imaging, Modelling, and Physiology of Aerosols and the Lung
Schoroeter, Jeffry