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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A Physiologically-Based Pharmacokinetic Model to Estimate Absorption and Bioavailability of Corticosteroid Nasal Sprays
Schroeter, J; Rose, M; Kimbell, J; Chopski, S; Walenga, R
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Effect of Polydispersity on PBPK Model Simulations of Intranasal Corticosteroid Sprays
Schroeter, Jeffrey; Rose, Morgan; Kimbell, Julia; Chopski, Steven; Walenga, Ross
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A CFD-PBPK Model to Simulate Nasal Absorption and Systemic Bioavailability of Intranasal Fluticasone Propionate
Schroeter, Jeffry; Kimbell, Julia; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar
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A Physiologically-Based Pharmacokinetic Model Framework To Estimate Systemic Bioavailability Of Fluticasone Propionate Nasal Spray
Schroeter, Jeffry; Stricklin, Daniela; Kimbell, Julia; Delvadia, Renishkumar; Zhang, Xinyuan
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The Impact Of Actuation Force On Droplet Size Distribution And Spray Duration Of Three Commercially Available Nasal Sprays
Schroeter, Jeffry; Kimbell, Julia; Saluja, Bhawana; Delvadia, Renishkumar; Vallorz-III, Ernest; Sheth, Poonam
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In Vitro Investigation of Regional Nasal Drug Delivery using Two Glucocorticoid Nasal Spray Products and Twenty Anatomical Nasal Replicas
Manniello, Michele; Hosseini, Sana; Hindle, Michael; Schuman, Theodore; Longest, Worth; Sandell, Dennis; Golshahi, Laleh
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How Spray Metric Variability Impacts the Initial Deposition of Nasal Sprays
Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Golshahi, Laleh; Hindle, Michael; Longest, Worth
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Effect of Spray Momentum on Nasal Spray Droplet Transport and Deposition
Kolanjiyil, Arun; Hosseini, Sana; Manniello, Michele; Alfaifi, Ali; Farkas, Dale; Golshahi, Laleh; Longest, Worth
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Estimating Size-specific Numbers of Active Pharmaceutical Ingredient Particles in the Regional Deposition of a Nasal Spray
Kimbell, Julia; Schroeter, Jeffry; Tian, Geng; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar
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Effect of Actuation Force on Simulated Regional Nasal Spray Deposition in a Healthy Nasal Cavity
Kimbell, Julia; Schroeter, Jeffry; Sheth, Poonam; Tian, Geng; Delvadia, Renishkumar; Saluja, Bhawana; Walenga, Ross