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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Deposition of Particles in the Alveolar Airways: Inhalation and Breath-Hold with Pharmaceutical Aerosols
Longest, Worth
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In Vivo-Relevant Transwell Dish-Based Dissolution Testing for Orally Inhaled Corticosteroid Products
Sakagami, Masahiro; Li, Hua; Venitz, Jugen
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In Vitro Investigations into Batch-to-Batch Variability in a Fluticasone Propionate and Salmeterol Dry Powder Inhaler
Herpin, Matthew; Hefnawy, Amr; Smyth, Hugh
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Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA
Wang, Zhong; Ahluwalia, Sharon; Newman, Bryan; Dhapare, Sneha; Zhao, Liang; Luke, Markham
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Characterization of Particle Size Distributions Respiratory Tract Deposition of Albuterol Sulfate Metered Dose Inhalers
Schroeter, Jeffry; Holt, Jay; Asgharian, Bahman; Bovet, Jean Marc; Hickey, Anthony
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Evaluating Electrostatic Drug Deposition in Plastic Mouth-Throat Models with Budelin Novolizer
Huynh, Bao; Wei, Xiangyin; Byron, Peter
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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