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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Modifications To The Multiple-Path Particle Dosimetry Model For Improved Predictions Of Lung Deposition From Metered Dose Inhalers
Schroeter, Jeffry; Asgharian, Bahman; Price, Owen; Holt, Jay; Hickey, Anthony
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Characterization Of Particle Size Distributions And Respiratory Tract Deposition Of Albuterol Sulfate Metered Dose Inhalers
Schroeter, Jeffry; Holt, Jay; Asgharian, Bahman; Bovet, Jean-Marc; Hickey, Anthony
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Coating Stages of Next Generation Impactor (NGI) When Testing Metered Dose Inhalers (MDIs) – A Comparative Study on US Commercial MDI Products
Sandell, Dennis; Svensson, Marten; Conti, Denise; Sheth, Poonam; Oguntimein, Oluwamurewa; Bielski, Elizabeth; Bulitta, Jurgen; Hochhaus, Gunther
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Development of an In Vitro Permeation Test to Predict the In Vivo Performance of Naloxone Hydrochloride Nasal Spray Products
Qarterman, Juliana; Al Ghabeish, Manar; Newman, Bryan; Walenga, Ross; Chopski, Steven; Zidan, Ahmed; Pavuluri, Venkateswara; Shakleya, Diaa; Li, Min; Ashraf, Muhammad
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Development of a Low-Volume In-Vitro Dissolution Method for Assessing Variability in Fine Particle Doses of Dry Powder Inhalers
Nair, Varsha; Hefnawy, Amr; Herpin, Matthew; Feng, Kairui; Reed, Nathan; Ma, Tian; Bielski, Elizabeth; Dhapare, Sneha; Newman, Bryan; Boc, Susan; Smyth, Hugh
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In Vitro Batch-to-Batch Variability of Fluticasone Propionate and Salmeterol Dry Powder Inhalers
Nair, Varsha; Hefnawy, Amr; Smyth, Hugh; Lee, Jieon; Feng, Kairui; Bielski, Elizabeth; Dhapare, Sneha; Newman, Bryan; Conti, Denise; Boc, Susan; Herpin, Matthew
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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