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)

• The Effects of Upper Airway Tissue Motion on Airflow Dynamics

  Zhao, Yongling; Raco, Joel; Kourmatzis, Agisilaos; Diasinos, Sammy; Chan, Hak Kim; Yang, Runyu; Cheng, Shaokoon

• On the Importance of Liquid Motion in Nasal Spray Delivery

  Kolanjiyil, AV; Golshahi, L; Longest, P

• Multilinear Calibration Of Lattice Boltzmann Pmdi Spray Simulation

  Mitran, Sorin; Hickey, Anthony; Holt, Jay

• iBCS: 1. Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System

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

• Investigating the Microstructure of Breo® Ellipta® Using Orthogonal Analytical Approaches

  Farias, Goncalo; Penas, Abel Gracia; Pinto, Sara; Silva, Lucas; Price, Robert; Shur, Jagdeep

• The Influence of Secondary Processing on the Structural Relaxation Dynamics of Fluticasone Propionate

  Depasquale, Roberto; Lee, Sau; Saluja, Bhawana; Shur, Jagdeep; Price, Robert

• Scientific and Regulatory Activities Initiated by the U.S. Food and Drug Administration to Foster Approvals of Generic Dry Powder Inhalers: Bioequivalence Perspective

  Newman, Bryan; Babiskin, Andrew; Bielski, Elizabeth; Boc, Susan; Dhapare, Sneha; Fang, Lanyan; Feibus, Karen; Kaviratna, Anubhav; Li, Bing V; Luke, Markham; Ma, Tian; Walenga, Ross; Wang, Zhong; Zhao, Liang; El-Gendy, Nashwa; Bertha, Craig; El-Shafy, Mohammed; Gaglani, Dhaval

• Estimating Aerosol Size Distributions and Doses Entering the Trachea

  Byron, Peter; Wei, Xiangyin; Bormann, Katharina

• Effects of Dose Loading Conditions and Device Geometry on the Transport and a Aerosolization in Dry Powder Inhalers: A Simulation Study

  Sulaiman, Mostafa; Liu, Xiaoyu; Sundaresan, Sankaran

• Comparing MDI and DPI Aerosol Deposition Using In Vitro Experiments and a New Stochastic Individual Path (SIP) Model of the Conducting Airways

  Longest, Worth; Tian, Geng; Walenga, Ross; Hindle, Michael