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)

• Assessment of Drug Permeability Using a Lung Microphysiological System

  Geiger, Robert M; Rahman, Shekh; Roni, Md Shadiqur Rashid; Tariq, Isra; Ismaiel, Omnia; Shea, Katherine; Matta, Murali; Ribeiro, Alexandre; Jiang, Wenlei; Walenga, Ross; Newman, Bryan; Ford, Kevin

• Investigation of Surface Characteristics of Micronized Salbutamol Sulphate Particles Formulated in Different Propellants Using Integrated Scanning Electron Microscopy & Atomic Force Microscopy

  Zapata Del Bano, Antonia; Silva, Lucas; Ulc, Filip; Hegrova’, Veronika; Deraime, Gregoire; Paul, Aurore; Han, Liangfeng; Bielski, Elizabeth; Newman, Bryan; Shur, Jag

• The Use of Atomic Force Microscope-Infrared Spectroscopy to Assess Co-localization of Fluticasone Propionate/Salmeterol Xinafoate/Lactose Monohydrate in Advair Diskus 100/50 and Wixela Inhub 100/50

  Joseph, Blessy; Khanal, Dipesh; Bielski, Elizabeth; Newman, Bryan; Yilmaz, Huzeyfe; Ahmed, Snober; Boc, Susan; Chan, Hak-Kim; Holl, Mark Banaszak

• Use of High-speed Particle Imaging to Delineate between Different Inhalation Powder Blends

  Milton-Mcgurk, L; Mekonnen, TT; Kourmatzis, A; Tai, Waiting; Chan, Hak-Kim; Boc, Susan; Singh, Gajendra; Cheng, Shaokoon

• Novel Method for Droplet Size Distribution Measurements from Respimat Inhalers

  Chopski, Steven; Hu, Meng; Walenga, Ross; Boc, Susan; Newman, Bryan; Kakhi, Maziar; Zhao, Liang; Guha, Suvajyoti

• Facilitating Drug Development Through GDUFA Regulatory Science and Research Opportunities for Collaboration with FDA

  Chakma, Monbi S; Usmani, Omar; Meah, Sally; Biddiscombe, Martyn; Bielski, Elizabeth; Feibus, Katharine; Natarajan, Karthika; Li, Karen; Kinjo, Minori; Illoh, Onyekachukwu; Han, Liangfeng; Newman, Bryan; Murnane, Darragh

• Development of a CFD PK Nasal Spray Model with In Vivo Human Subject Validation

  Dutta, R; Kolanjiyil, AV; Golshahi, L; Longest, W

• Droplet Evaporation from a Solution-Based Metered Dose Inhaler: A Computational Approach

  Walenga, Ross; Conti, Denise; Oguntimein, Oluwamurewa; Delvadia, Renishkumar; Rygg, Alex; Babiskin, Andrew

• The Influence Of Formulation Variables On Mometasone Furoate pMDIs

  Sheth, Poonam; Sandell, Dennis; Svensson, Marten; Vallorz-III, Ernest; Sullivan, Jamie; Saluja, Bhawana; Conti, Denise

• A Dual-Internal Standard Lc-Uv-Msd Method To Improve Accuracy And Efficiency Of Characterizing Mometasone Furoate Mdis

  Sheth, Poonam; Vallorz-III, Ernest; Susick, Robert; Menzeleev, Ramil