GDUFA Research Outcomes
Inhalation Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the inhalation route, including orally inhaled products.
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Application of the Dose-Scale Method for Pharmacodynamic Bioequivalence Studies of Orally Inhaled Drug Products
Kim, Stephanie; Lee, Sau; Lionberger, Robert
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Clinically Relevant in Vitro Performance Tests for Powder Inhalers
Byron, Peter
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A Quasi-3D Compartmental Multi-Scale Approach to Detect and Quantify Diseased Regional Lung Constriction Using Spirometry Data
Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej
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Modifications To The Multiple-Path Particle Dosimetry Model For Improved Predictions Of Lung Deposition From Metered Dose Inhalers
Schroeter, Jeffry; Asgharian, Bahman; Price, Owen; Holt, Jay; Hickey, Anthony
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The Effects of Upper Airway Tissue Motion on Airflow Dynamics
Zhao, Yongling; Raco, Joel; Kourmatzis, Agisilaos; Diasinos, Sammy; Chan, Hak Kim; Yang, Runyu; Cheng, Shaokoon
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On the Importance of Liquid Motion in Nasal Spray Delivery
Kolanjiyil, AV; Golshahi, L; Longest, P
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iBCS: 1. Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System
Hastedt, Jayne; Backman, Per; Cabal, Antonio; Clark, Andy; Ehrhardt, Carsten; Forbes, Ben; Hickey, Anthony; Hochhaus, Gunther; Jiang, Wenlei; Kassinos, Stavros; Kuehl, Philip; Prime, David; Son, Yoen-Ju; Teague, Simon; Tehler, Ulrika; Wylie, Jennifer
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Multilinear Calibration Of Lattice Boltzmann Pmdi Spray Simulation
Mitran, Sorin; Hickey, Anthony; Holt, Jay
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The Influence of Secondary Processing on the Structural Relaxation Dynamics of Fluticasone Propionate
Depasquale, Roberto; Lee, Sau; Saluja, Bhawana; Shur, Jagdeep; Price, Robert
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Investigating the Microstructure of Breo® Ellipta® Using Orthogonal Analytical Approaches
Farias, Goncalo; Penas, Abel Gracia; Pinto, Sara; Silva, Lucas; Price, Robert; Shur, Jagdeep