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(302)
• Posters(57)
• Presentations(136)
• Papers(109)

• Modeling Lung Transporters and Their Influence on Inhaled Drug Disposition

  Yeshwante, Shekhar; Mahadevan, Ramya; Sule, Olagoke; Tiley, Jacqueline B; Luterbach, Courtney L; McCann, Sean; Fallon, John K; Smith, Philip C; Tan, Ming-Liang; Walenga, Ross; Newman, Bryan; Zhao, Liang; Gentzsch, Martina; Esther Jr, Charles R; Rao, Gauri G

• Evaluating 3D-Printed Pre-separator Inserts in a Fast Screening Impactor for Physicochemical Characterization of Fine Particle Dose Release from Dry Powder Inhalers

  Reed, Nathan; Dar, Roee; Holtgrewe, Nicholas; Cao, Leo N Y; Liu, Xiaofei; Conti, Denise S; Newman, Bryan; Bielski, Elizabeth; Rodriguez, Jason D; Guo, Changning

• Assessment of Drug Permeability Using a Small Airway Microphysiological System

  Geiger, Robert; Rahman, Shekh; Rashid Roni, Md Shadiqur; Sullenberger, Catherine; Mistry, Sabyasachy; Shea, Katherine; Tariq, Isra; Ismaiel, Omnia; Matta, Murali; Hyland, Paula; Berdichevski, Sasha; Ribeiro, Alexandre; Blinova, Ksenia; Jiang, Wenlei; Walenga, Ross; Newman, Bryan; Volpe, Donna; Ford, Kevin

• Assessment of Ventilation Heterogeneity and Particle Deposition in Asthmatics using Combined SPECT/CT Imaging and Computational Modeling Approaches

  Zhang, Xuan; Rajaraman, Pratish K; Li, Frank; Choi, Sanghun; Comellas, Alejandro P; Hoffman, Eric A; Fain, Sean B; Kaczka, David W; Smith, Benjamin M; Choi, Jiwoong; Castro, Mario; Wenzel, Sally; Jarjour, Nizarn; Schiebler, Mark L; Israel, Elliot; Levy, Bruce D; Fahy, John V; Erzurum, Serpil C; Babiskin, Andrew; Kinjo, Minori; Walenga, Ross; Lin, Ching-Long

• Quantitative Morphological Analysis of Multiparticle Aggregates

  Holl, Mark Banaszak

• Materials for Inhaled Aerosol Treatment of Disease: Can O-PTIR Microscopy be employed as a Tool to Evaluate the Complex Powder Nanostructure?

  Holl, Mark Banaszak

• Materials for Inhaled Aerosol Treatment of Disease: Optical Photothermal Infrared Microscopy (O-PTIR) as an Advanced Characterization Method for Assessing the Emitted Dose of Complex Dry Powder Inhaler Formulations

  Holl, Mark Banaszak

• FDA’s Option-Based BE Approach Recommendations for Locally Acting Metered Dose Inhalers and Dry Powder Inhalers

  Han, Liangfeng

• FDA’s Option-Based BE Approach Recommendations for Locally Acting Metered Dose Inhalers and Dry Powder Inhalers

  Bielski, Elizabeth

• FDA’s Current Perspectives on the Propellant Transition: Work Towards Global Harmonization

  Bielski, Elizabeth