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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Development of a CFD-PK Nasal Spray Model with In Vivo Human Subject Validation
Dutta, R; Kolanjiyil, AV; Golshahi, L; Longest, P
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In Vitro Tests for Aerosol Deposition V: Using Realistic Testing to Estimate Variations in Aerosol Properties at the Trachea
Wei, Xiangyin; Hindle, Michael; Delvadia, Renishkumar; Byron, Peter
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Transport and Deposition of Hygroscopic Particles in Asthmatic Subjects with and without Airway Narrowing
Rajaraman, Prathish; Choi, Jiwoong; Hoffman, Eric; O’shaughnessy, Patrick; Choi, Sanghun; Delvadia, Renishkumar; Babiskin, Andrew; Walenga, Ross; Lin, Chinglong
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Validating CFD Predictions of Highly Localized Aerosol Deposition in Airway Models: In Vitro Data and Effects of Surface Properties
Longest, Worth
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Effects of Subject-Variability on Nasally Inhaled Drug Deposition, Uptake, and Clearance
Chari, Sriram; Sridhar, Karthik; Kleinstreuer, Clement
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Systematic Evaluation of the Effect of Formulation Variables on In Vitro Performance of Mometasone Furoate Suspension-Metered Dose Inhalers
Bachhav, Sagar; Sheth, Poonam; Sandell, Dennis; Svensson, Marten; Bhagwat, Sharvari; Conti, Denise; Oguntimein, Oluwamurewa; Dhapare, Sneha; Saluja, Bhawana; Winner, Lawrence; Bulitta, Jurgen; Hochhaus, Gunther
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A quasi-3D model of the whole lung: airway extension to the tracheobronchial limit using the constrained constructive optimization and alveolar modeling, using a sac–trumpet model
Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej; Zhou, Xianlian; Walenga, Ross; Babiskin, Andrew
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Application of the Modified chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing
Weber, Benjamin; Lee, Sau; Delvadia, Renishkumar; Lionberger, Robert; Li, Bing; Tsong, Yi; Hochhaus, Guenther
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Use of Realistic Testing for Lifecycle Changes: A Proposal for Discussion and Possible Future Regulatory Guidance
Sandell, Dennis
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A Compartment-Quasi-3D Multiscale Approach for Drug Absorption, Transport, and Retention in the Human Lungs
Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej