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.

• All(283)
• Posters(52)
• Presentations(126)
• Papers(105)

• 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

• 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

• 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

• Effects of Formulation Factors on the Aerosolization Performance of Metered Dose Inhalers

  Conti, Denise; Holt, Jay; Sheth, Poonam; Sandell, Dennis; Hickey, Anthony; Saluja, Bhawana

• 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

• 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

• Investigation of Pharmacokinetic Sensitivity to Lung Deposition of Locally-Acting Orally Inhaled Drug Products

  Boc, Susan; Conti, Denise; Chen, Mong Jen; Jiao, Yuanyuan; Kurumaddali, Abhinav; Oguntimein, Oluwanurewa; Delvadia, Renishkumar; Saluja, Bhawana; Lee, Sau; Shur, Jag; Price, Rob; Hindle, Michael; Bulitta, Jurgen; Hochhaus, Gunther

• Investigation of Pharmacokinetic Sensitivity to Lung Deposition of Locally-Acting Orally Inhaled Drug Products

  Boc, Susan; Conti, Denise; Chen, Mong Jen; Jiao, Yuanyuan; Kurumaddali, Abhinav; Oguntimein, Oluwanurewa; Delvadia, Renishkumar; Saluja, Bhawana; Lee, Sau; Shur, Jag; Price, Rob; Hindle, Michael; Bulitta, Jurgen; Hochhaus, Gunther

• The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler In Vitro Aerosolization Performance

  Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Hallinger, Madeline; Svensson, Marten; Sandell, Dennis; Bulitta, Juergen; Hochhaus, Gunther

• The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler Performance

  Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Hallinger, Madeline; Svensson, Marten; Sandell, Dennis; Bulitta, Jurgen; Hochhaus, Gunther