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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Measurement of Drug in Small Particles from Aqueous Nasal Sprays by Andersen Cascade Impactor
Doub, William; Adams, Wallace; Wokovich, Anna; Black, John; Shen, Meiyu; Buhse, Lucinda
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A Physiologically-Based Pharmacokinetic Model Framework To Estimate Systemic Bioavailability Of Fluticasone Propionate Nasal Spray
Schroeter, Jeffry; Stricklin, David; Kimbell, Julia; Delvadia, Renishkumar
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In Vitro Evaluation of Regional Nasal Drug Delivery Using Multiple Anatomical Nasal Replicas of Adult Human Subjects and Two Nasal Sprays
Manniello, Michele; Hosseini, Sana; Alfaifi, Ali; Esmaeili, Amir; Kolanjiyil, Arun; Walenga, Ross; Babiskin, Andrew; Sandell, Dennis; Mohammadi, Reza; Schuman, Theodore; Hindle, Michael; Golshahi, Laleh
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Anatomically Realistic Nasal Replicas Capturing the Range of Nasal Spray Drug Delivery in Adults
Alfaifi, A; Hosseini, S; Esmaeili, A; Walenga, R; Babiskin, A; Schuman, T; Longest, W; Hindle, M; Golshahi, L
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Importance of Cloud Motion and Two-way Momentum Coupling in the Transport of Pharmaceutical Nasal Sprays
Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Hindle, Michael; Golshahi, Laleh; Longest, Worth