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)

• Clinically Relevant In Vitro Tests for the Assessment of Innovator and Generic Nasal Spray Products

  Azimi, Mandana; Longest, P Worth; Shur, Jag; Price, Robert; Hindle, Michael

• Evaluating the Dissolution of Commercially Available Metered Dose Inhaler (MDI) Drug Products from Realistic In Vitro Experiments

  Mohan, Abhinav; Berger, Simon; Dhapare, Sneha; Newman, Bryan; Svensson, Marten; Elfman, Peter; Winner, Lawrence; Bulitta, Jurgen; Hochhaus, Gunther

• Method for Exploring the Evaporation of pMDI Propellant Droplets with Microsecond Time Resolution

  Hardy, Daniel; Legh-Land, Victoria; Haddrell, Allen; Ganley, William; Paul, Aurore; Deraime, Gregoire; Han, Liangfeng; Bielski, Elizabeth; Newman, Bryan; Shur, Jag

• Characterization of Spray-dried Phospholipid Porous Particles for Inhalation Drug Delivery

  Boc, Susan; Wanasathop, Apipa; Sonju, Jafrin Jobayer; Mohan, Abhinav; Dhapare, Sneha; Bielski, Elizabeth; Newman, Bryan; Ashraf, Muhammad; Xu, Xiaoming; Wang, Yan

• Understanding How the Manufacturing Process Affects the Quality of Spray-dried Phospholipid Porous Particles for Inhalation

  Yang, Yang; Wanasathop, Apipa; Zhang, Yuan; Sonju, Jafrin Jobayer; Mohan, Abhinav; Boc, Susan; Dhapare, Sneha; Bielski, E; Newman, Bryan; Ashraf, Muhammad; Xu, Xiamoning

• Atomic Force Microscope-Infrared Spectroscopy as a Powerful Tool to Study the Distribution of Fluticasone Propionate/Salmeterol Xinafoate/Lactose Monohydrate in Advair Diskus 100/50 Formulations

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

• Optical Photothermal Infrared Spectroscopic Assessment of Fluticasone/Salmeterol/Lactose Co-Association in Advair Diskus 100/50 and Wixela Inhub 100/50

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

• Evaluation Permeation and Leachable Characteristics in Metered Dose Inhalers

  Behem, Patrice; Paul, Aurore; Deraime, Gregoire; Hegrova’, Veronika; Dao, Radek; Han, Liangfeng; Bielski, Elizabeth; Newman, Bryan; Shur, Jagdeep

• Comparison of Generic and Brand Name Dry Powder Inhalers: Advanced Insights Using Optical Photothermal Infrared Microscopy

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

• 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