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)

• Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability

  Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Jogarao

• Novel Method for Aerodynamic Particle Size Distribution Measurements from Respimat® Inhalers

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

• CFD-DEM Investigation of the Effects of Aperture Size for a Capsule-based Dry Powder Inhaler

  Zhu, Qixuan; Kakhi, Maziar; Jayasundara, Chandana; Walenga, Ross; Behara, Srinivas; Chan, Hak Kim; Yang, Runyu

• iBCS: 3. A Biopharmaceutics Classification System for Orally Inhaled Drug Products

  Hastedt, Jayne; Backman, Per; Cabal, Antonio; Clark, Andy; Ehrhardt, Carsten; Forbes, Ben; Hickey, Anthony; Hochhaus, Gunther; Jiang, Wenlei; Kassinos, Stavros; Kuehl, Philip J; Prime, David; Son, Yoen-Ju; Teague, Simon P; Tehler, Ulrika; Wylie, Jennifer

• Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease

  Clerman, Andrew; Luke, Markham

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

  Khanal, Dipesh; Haque, Sheikh Tanzina; Joseph, B; Bielski, Elizabeth; Newman, Bryan; Yilmaz, H; Ahmed, S; Boc, Susan; Chan, Hak Kim; Banaszak Holl, M

• A 3D Model of the Human Lung Airway for Evaluating Permeability of Inhaled Drugs

  Rahman, Shekh M; Geiger, Robert M; Roni, Md Shadiqur Rashid; Tariq, Isra; Ismaiel, Omnia; Matta, Murali K; Shea, Katherine; Bruckner, Dylan; Jiang, Wenlei; Walenga, Ross; Newman, Bryan; Hyland, Paula; Ribeiro, Alexandre; Florian, Jeffrey; Blinova, Ksenia; Ford, Kevin A

• Characterizing Adasuve® (Loxapine, 10 mg) Inhalation Powder Particle Size Distribution Using Laser Diffraction

  Reed, Nathan; Lee, Y; Ballard, Betsy; Feibus, Katharine; Luke, Markham; Changning, Guo

• Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques

  Farias, Goncalo; Ganley, William; Price, Robert; Conti, Denise S; Mangal, Sharad; Bielski, Elizabeth; Newman, Bryan; Shur, Jagdeep

• The Use of Atomic Force Microscope0Infrared Spectroscopy to Assess Co-Localization of Fluticasone/ Salmeterol/ Lactose in Advair Diskus® 100/50 Formulations

  Joseph, B; Khanal, D; Bielski, Elizabeth; Newman, Bryan; Yilmaz, H; Ahmed, S; Boc, Susan; Chan, H; Banaszak Holl, M