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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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
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Enhanced Analytical Tools for Bioequivalence Evaluation of Nasal Spray Drug Products
Rodriguez, Jason
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Development of Enhanced Analytical Tools for Evaluation of Complex Generic Products
Rodriguez, Jason
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Addressing the Challenges with Orally Inhaled and Nasal Drug Products (OINDPs) Through the Pre-ANDA Meeting Process
Newman, Bryan; Dhapare, Sneha; Walenga, Ross; Feng, Kairui
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Nasal Products: Current Landscape and Recent Advancements
Newman, Bryan
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Overview of Complex Generic Inhalation and Nasal Drug-Device Combination Products
Newman, Bryan