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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Impact of Orally Inhaled and Nasal Drug Product PBPK Models on Product Development and Regulatory Decision Making
Walenga, Ross
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Computational Fluid Dynamics (CFD) Modeling for Product Development of Generic OINDPs and for Supporting Novel BE Approaches
Walenga, Ross
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Powder Fluidization in Dry Powder Inhalers
Sulaiman, Mostafa; Liu, Xiaoyu; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran
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A Multiscale Computational Framework for Inhalation Pharmacology and Drug Development
Singh, Narender; Kannan, Ravi; Przekwas, Andrzej
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A Predictive Multiscale Computational Tool for Simulation of Lung Absorption and Pharmacokinetics and Optimization of Pulmonary Drug Delivery
Singh, Narender
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Effect of Varying Inflow Conditions on Pharmaceutical Powder Dynamics in Inhaler-like Flows
Singh, Gajendra
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The Development of Predictive Dissolution Methods for Orally Inhaled Drug Products
Shur, Jag
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Unraveling the Pulmonary Fate of Fluticasone and Friends: Meeting the Physiologic and Pharmacokinetic Challenge
Hochhaus, Guenther
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Dissolution Methodologies
Hochhaus, Gunther
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Exploring the Relationship between Suspension and Solution MDI Formulation Variables and Predicted Lung Deposition
Schoroeter, Jeffry