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)

• 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

• 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

• Quantitative Characterization of Circadian Rhythm of Pulmonary Function in Asthmatic Patients Treated with Inhaled Corticosteroids

  Zhou, Di; Li, Hongshan; Wang, Yaning; Hochhaus, Guenther; Sinha, Vikram; Zhao, Liang

• The Influence Of Formulation Variables On Mometasone Furoate pMDIs

  Sheth, Poonam; Sandell, Dennis; Svensson, Marten; Vallorz, Ernest; Sullivan, Jamie; Saluja, Bhawana; Conti, Denise

• Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

  Lee, Jieon; Feng, Kairui; Conti, Denise; Walenga, Ross; Wientijes, Michael; Wang, Hezhen; Newman, Bryan; Han, Liangfeng; Dhapare, Sneha; Bielski, Elizabeth; Babiskin, Andrew; Wu, Fang; Donnelly, Mark; Kim, Myong-Jin; Jiang, Wenlei; Luke, Markham; Fang, Lanyan; Zhao, Liang

• Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?

  Hochhaus, Gunther; Chen, Mong Jen; Kurumaddali, Abhinav; Schilling, Uta; Jiao, Yuanyuan; Drescher, Stefanie; Amini, Elham; Kandala, Bhargava; Tabulov, Christine; Shao, Jie; Seay, Brandon; Abu-Hasan, Mutasim; Baumstein, Sandra; Winner, Lawrence; Shur, Jagdeep; Price, Robert; Hindle, Michael; Wei, Xiangyin; Carrasco, Cynthia; Sandell, Dennis; Oguntimein, Oluwamurewa; Kinjo, Minori; Delvadia, Renishkumar; Saluja, Bhawana; Lee, Sau; Conti, Denise; Bulitta, Jurgen

• Evaluation of the Fast Screening Impactor with Dry Powder Inhalers

  Holtgrewe, Nicholas; Reed, Nathan; Kaviratna, Anubnav; Rodriguez, Jason; Guo, Changning

• Predictive In Vitro Dissolution Methods for Orally Inhaled Drug Products

  Price, Robert