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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Bioequivalence Testing: Can Systemic Pharmacokinetic Profiles From Corticosteroid Nasal Sprays Be Used To Elucidate Local Drug Deposition Within The Nose?
Longest, Worth; Rygg, Alex; Hindle, Michael
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New Tools for Generic OIDPs to Maximize Prospects of FDA Approval
Lionberger, Robert
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Session 4: Computational Models to Understand In Vivo Performance of OINDPs
Liang, Zhao
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Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products
Li, Matt (Zhichuan)
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Session 2: Novel Analytical Tools for Characterization of Nasal Suspensions
Jiang, Xiaohui
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Evaluating Particle Size Differences of Suspension-based Nasal Sprays Through In Vitro and Pharmacokinetic Approaches
Hochhaus, G; Amini, E; Berger, S; Shur, J; Kurumaddali, A; Schilling, U; Jiao, Y; Drescher, S; Seay, B; Baumstein, S; Abu Hasan, M; Oguntimein, O; Carrasco, C; Winner, L; Delvadia, R; Saluja, B; Price, R; Conti, D; Dhapare, S; Newman, B; Bulitta, J
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Comparing Nasal Suspension Products Using Realistic In Vitro Test Methods
Hindle, Mike
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The Potential of Pharmacokinetic Bioequivalence (BE) Studies in Detecting Regional Deposition with Orally Inhaled Drug Products
Han, Liangfeng
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Analytical Method Development for Ingredient-Specific Particle Sizing of Nasal Spray Suspensions
Guo, Changning
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Pathways to Establish Bioequivalence and Facilitate Development of Innovative and Generic Intranasal Drug Delivery Products: In vitro Anatomically Correct Nasal Models
Golshahi, Laleh