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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Evaluation of the Fast Screening Impactor with Dry Powder Inhalers
Holtgrewe, Nicholas; Reed, Nathan; Kaviratna, Anubhav; Rodriguez, Jason; Guo, Changning
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The Influence Of Formulation Variables On The Performance Of A Beclomethasone Dipropionate Metered Dose Inhaler
Holt, Jay; Hickey, Anthony; Vallorz-III, Ernest; Straughn, Kevin
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Influence Of Formulation Factors On Particle Size Distributions And Respiratory Tract Deposition Of Metered Dose Inhalers
Holt, Jay; Vallorz-III, Ernest; Straughn, Kevin
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Investigation of the Effects of Physicochemical Properties of Dry Powder Inhalers on Batch-to-Batch Variability
Hefnawy, Amr; Herpin, Matthew; Nair, Varsha; Lee, Jieon; Feng, Kairui; Bielski, Elizabeth; Dhapare, Sneha; Newman, Bryan; Conti, Denise; Boc, Susan; Smyth, Hugh
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Assessing Central and Peripheral Pulmonary Deposition of Three Fluticasone Propionate Dry Powder Inhaler Formulations with Different Aerodynamic Particle Size Distributions in Healthy Subjects via Population Pharmacokinetics Modeling
Drescher, Stefanie; Chen, Mongjen; Urumaddali, Abhinav; Schilling, Uta; Jiao, Yuanyuan; Shao, Jie; Seay, Brandon; Baumstein, Sandra; Abu-Hasan, Mutasim; Winner, Lawrence; Tabulov, Christine; Shur, Jag; Price, Robert; Hindle, Michael; Wei, Xiangyin; Bulitta, J; Hochhaus, G
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Effects of Formulation and Actuator Design on Spray Pattern and Plume Geometry of Mometasone Furoate Metered Dose Inhalers (MDIs)
Dhapare, Sneha; Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Svensson, Marten; Sandell, Dennis; Bulitta, Juergen; Hochhaus, Gunther
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Effects of Formulation and Actuator Design on Spray Pattern and Plume Geometry of Mometasone Furoate Metered Dose Inhalers
Dhapare, Sneha; Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Hallinger, Madeline; Svensson, Marten; Sandell, Dennis; Bulitta, Jurgen; Hochhaus, Gunther
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Effects of Formulation Factors on the Aerosolization Performance of Metered Dose Inhalers
Conti, Denise; Holt, Jay; Sheth, Poonam; Sandell, Dennis; Hickey, Anthony; Saluja, Bhawana
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Characteristics of Inhaled Particle Deposition in the Lungs of Imaging-based Asthma Clusters: a Numerical Study
Choi, Jiwoong; LeBlanc, Lawrence; Choi, Sanghun; Haghighi, Babak; Hoffman, Eric; O’Shaughnessy, Patrick; Wenzel, Sally; Castro, Mario; Fain, Sean; Jarjour, Nizar; Schiebler, Mark; Denlinger, Loren; Lin, Chinglong
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Dry Powder Inhaler (DPI) Resistance: Human Behaviour and Psychology of Patient Inspiratory Effort
Chakma, Monbi S; Meah, Sally; Biddiscombe, Martyn; Murnane, Darragh; Bielski, Elizabeth; Feibus, Katharine; Natarajan, Karthika; Li, Karen; Kinoj, Minori; Illoh, Onyekachukwu; Han, Liangfeng; Newman, Bryan; Usmani, Omar S