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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Prediction II: Computational Fluid Dynamics, as part of a workshop titled Bridging the Gap from Science to Clinical Efficacy: Imaging, Modelling, and Physiology of Aerosols and the Lung
Schoroeter, Jeffry
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Varying Particle Size And Excipient Levels For Three Mdis: Effects On In-Vitro Performance
Sandell, Dennis
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Discriminative in Vitro Dissolution Testing for Orally Inhaled Drug Products
Sakagami, Masahiro
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Development of Enhanced Analytical Tools fo Evaluation of Complex Generic Products
Rodriguez, Jason
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Enhanced Analytical Tools for Bioequivalence Evaluation of Nasal Spray Drug Products
Rodriguez, Jason
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Development of Enhanced Analytical Tools for Evaluation of Complex Generic Products
Rodriguez, Jason
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Global Bioequivalence Requirements for Orally Inhaled Drug Products (OIDPs)
Jiang, Wenlei
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Dissolution and Beyond: The Use of Advanced Structural Characterization Tool for Demonstrating Pharmaceutical Equivalence of Orally Inhaled Drug Products
Price, Robert
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Verifying the Hygroscopic Particle Growth Model during the Time Relevant to Lung Inspiration
O’Shaughnessy, Patrick; Altmaier, Ralph; Walenga, Ross; Lin, Ching-Long
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Addressing the Challenges with Orally Inhaled and Nasal Drug Products (OINDPs) Through the Pre-ANDA Meeting Process
Newman, Bryan; Dhapare, Sneha; Walenga, Ross; Feng, Kairui