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)

• Cascade Impactor Equivalence Testing: Comparison of the Performance of the Modified Chi-Square Ratio Statistic (mCSRS) with the Original CSRS and EMA’s Average Bioequivalence Approach

  Kurumaddali, Abhinav; Christopher, David; Sandell, Dennis; Strickland, Helen; Morgan, Beth; Bulitta, Juergen; Wiggerhorn, Christopher; Stein, Stephen; Lyapustina, Svetlana; Hochhaus, Guenther

• Generic Drug Device Combination Products: Regulatory and Scientific Considerations

  Choi, Stephanie; Wang, Yan; Conti, Denise; Raney, Sam; Delvadia, Renishkumar; Leboeuf, Andrew; Witzmann, Kimberly

• Predicting Systemic and Pulmonary Tissue Barrier Concentration of Orally Inhaled Drug Products

  Singh, Narender; Kannan, Ravi; Arey, Ryan; Walenga, Ross; Babiskin, Andrew; Przekwas, Andrzej

• Factors Influencing Plume Characteristics of Metered Dose Inhalers (MDIs) Following Passage through Bio-relevant Mouth-Throat Models

  Dhapare, Sneha; Newman, Bryan; Svensson, Marten; Elfman, Peter; Sandell, Dennis; Winner, Larry; Bulitta, Jurgen; Hochhaus, Gunther

• Effects of Formulation Variables on Lung Dosimetry of Albuterol Sulfate Suspension and Beclomethasone Dipropionate Solution Metered Dose Inhalers

  Schroeter, Jeffry; Sheth, Poonam; Hickey, Anthony; Asgharian, Bahman; Price, Owen; Holt, Jay; Conti, Denise; Saluja, Bhawana

• Leveraging In Vitro Bioequivalence Tests for Locally-Acting Suspension Nasal Sprays with Three Anatomically-Correct Replicas of Human Nasal Airways Representing Intersubject Variability

  Golshahi, L; Alfaifi, A; Hosseini, S; Esmaeili, AR; Hindle, M; Longest, P; Schuman, TA

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

  El-Gendy, Nashwa; Bertha, Craig M; El-Shafy, Mohammed; Gaglani, Dhaval; Babiskin, Andrew; Bielski, Elizabeth; Boc, Susan; Dhapare, Sneha; Fang, Lanyan(Lucy); Feibus, Karen; Kaviratna, Anubnav; Li, Bing; Luke, Markham C; Ma, Tian; Newman, Bryan; Walenga, Ross; Zhao, Liang

• Development of Characteristic Upper Tracheobronchial Airway Models for Testing Pharmaceutical Aerosol Delivery

  Walenga, Ross; Tian, Geng; Longest, Worth

• Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products: Workshop Summary Report.

  O’connor, Dennis; Adams, Wallace; Chen, Meiling; Daley Yates, Peter; Davis, John; Derendorf, Hartmut; Ducharme, Murray; Fuglsang, Anders; Herrle, Myra; Hochhaus, Guenther; Holmes, Susan; Lee, Sau; Li, Bing; Lyapustina, Svetlana; Newman, Stephen; Oliver, M

• Differences in Particle Deposition between Members of Imaging-Based Asthma Clusters

  Choi, Jiwoong; Leblanc, Lawrence; Choi, Sanghun; Haghighi, Babak; Hoffman, Eric; O’shaughnessy, Patrick; Wenzel, Sally; Castro, Mario; Fain, Sean; Jarjour, Nizar; Schielbler, Mark; Denlinger, Loren; Delvadia, Renishkumar; Walenga, Ross; Babiskin, Andrew; Lin, Ching-Long