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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Effect of Coating of Andersen Cascade Impactor and Next Generation Impactor on the Aerodynamic Particle Size Distribution of Nine Commercial Metered Dose Inhalers
Mohan, Abhinav; Dhapare, Sneha; Newman, Bryan; Svensson, Marten; Elfman, Peter; Stuckel, Jackie; Sandell, Dennis; Winner, Lawrence; Bulitta, Jurgen; Hochhaus, Gunther
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Multilinear Calibration Of Lattice Boltzmann Pmdi Spray Simulation
Mitran, Sorin; Hickey, Anthony; Holt, Jay
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Microstructural Mapping of Dry Powder Inhalers (DPIs) Using Morphologically Directed Raman Spectroscopy (MDRS): A Novel Analytical Tool for DPI Characterization
Mangal, Sharad; Conti, Denise; Delvadia, Renishkumar; Oguntimein, Oluwamurewa; Shur, Jagdeep; Price, Robert
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Microstructural Mapping of Dry Powder Inhalers (DPIs) Using Morphologically Directed Raman Spectroscopy (MDRS): A Novel Analytical Tool for DPI Characterization
Mangal, Sharad; Conti, Denise; Delvadia, Renishkumar; Oguntimein, Oluwamurewa; Shur, Jagdeep; Price, Robert
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A Semi-physiological Approach for Evaluating the Sensitivity of Pharmacokinetics to Detect Differences in Regional Lung Deposition of Orally-inhaled Drug Products (OIDPs)
Kurumaddali, Abhinav; Amini, Elham; Drescher, Stefanie; Chen, Mongjen; Bulitta, Jurgen; Hochhaus, Gunther
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Inhalation Profile Modeling For Fluticasone Propionate Dry Powder Inhalers In Healthy Volunteers During A Four Way Crossover Bioequivalence Study
Kurumaddali, Abhinav; Schilling, Uta; Chen, Mongjen; Jiao, Yuanyuan; Seay, Brandon; Baumstein, Sandra; Abu-Hasan, Mutasim; Conti, Denise; Oguntimein, Oluwamurewa; Delvadia, Renishkumar; Winner, Lawrence; Tabulov, Christine; Saluja, Bhawana; Bulitta, Jurge
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On the Importance of Liquid Motion in Nasal Spray Delivery
Kolanjiyil, A; Golshahi, L; Longest, W
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Evaluation of Bio-Relevant Mouth-Throat (MT) Models to Determine the Aerosol Deposition and Particle Size Distribution of QVAR Using Cascade Impactor
Kaviratna, Anubhav; Liu, Xiaofei; Delvadia, Renishkumar; Guo, Changning
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A Multiscale Modeling Approach To Optimize Pulmonary Drug Delivery
Kannan, Ravi; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross
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Factors Influencing Plume Characteristics of Flovent® HFA Following Passage through Bio-Relevant Mouth-Throat Models
Kaisar, Md Abul; Dhapare, Sneha; Newman, Bryan; Svensson, Marten; Sandell, Dennis; Bulitta, Jurgen; Hochhaus, Gunther