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(217)
• Posters(37)
• Presentations(91)
• Papers(89)

• 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

• International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

  Lu, Dongmei; Lee, Sau; Lionberger, Robert; Choi, Stephanie; Adams, Wallace; Caramenico, Hoainhon; Chowdhury, Badrul; Conner, Dale; Katial, Rohit; Limb, Susam; Peters, John; Yu, Lawrence; Seymour, Sally; Li, Bing

• Demonstrating Q3 Structural Equivalence of Dry Powder Inhaler Blends: New Analytical Concepts and Techniques

  Price, Robert; Farias, Goncalo; Ganley, William; Shur, Jagdeep

• New Tools for Generic Orally Inhaled Drug Products to Maximize Prospects of Food and Drug Administration Approval

  Lionberger, Robert

• Validating CFD Predictions of Pharmaceutical Aerosol Deposition with In Vivo Data

  Tian, Geng; Hindle, Michael; Lee, Sau; Longest, Worth

• Optimization of the Transwell® System for Assessing the Dissolution Behavior of Orally Inhaled Drug Products through In Vitro and In Silico Approaches

  Amini, Elham; Kurumaddali, Abhinav; Bhagwat, Sharvari; Berger, Simon; Hochhaus, Gunther

• Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

  Price, Robert; Shur, Jagdeep; Ganley, William; Farias, Goncalo; Fotaki, Nikoletta; Conti, Denise; Delvadia, Renishkumar; Absar, Mohammad; Saluja, Bhawana; Lee, Sau