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.
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Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India
Lee, Sau; Saluja, Bhawana; Garcia Arieta, Alfredo; Santos, Gustavo; Li, Ying; Lu, Sarah; Hou, Shuguang; Rebello, Juliet; Vaidya, Abhijit; Gogtay, Jaideep; Purandare, Shrinivas; Lyapustina, Svetlana
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Evaluation of Statistical Methods for Determining Equivalence of Aerodynamic Particle Size Distribution
Weber, Benjamin; Adams, Wallace; Lionberger, Robert; Li, Bing; Tsong, Yi; Hochhaus, Guenther; Lee, Sau
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Pharmaceutical Aerosols Deposition Patterns from a Dry Powder Inhaler: Euler Lagrangian Prediction and Validation
Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross
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Unraveling the Pulmonary Fate of Fluticasone and Friends: Meeting the Physiologic and Pharmacokinetic Challenges
Hochhaus, Guenther; Chen, Mongjen; Shur, Jagdeep; Kurumaddali, Abhinav; Schilling, Uta; Jiao, Yuanyuan; Drescher, Stefanie; Amini, Elham; Seay, Brandon; Baumstein, Sandra; Abu Hasan, Mutasim; Hindle, Michael; Wei, Xiangyin; Oguntimein, Oluwamurewa; Carrasco, Cynthia; Winner, Lawrence; Delvadia, Renishkumar; Saluja, Bhawana; Kandala, Bhargava; Sandell, Dennis; Lee, Sau; Price, Robert; Conti, Denise; Bulitta, Jurgen
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A Quasi-3D Wire Approach to Model Pulmonary Airflow in Human Airways
Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross
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Particle-based coarse-grained approach for simulating dry powder inhaler
Liu, Xiaoyu; Sulaiman, Mostafa; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran
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Effects of Device and Formulation on In Vitro Performance of Dry Powder Inhalers
Adams, Wallace; Lee, Sau; Plourde, Robert; Lionberger, Robert; Bertha, Craig; Doub, William; Bovet, Jean Marc; Hickey, Anthony
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Modren Analytics For Synthetically Derived Complex Drug Substances: NMR, AFFF-MALS, and MS Tests For Glatiramer Acetate
Rogstad, Sarah; Pang, Eric; Sommers, Cynthia; Hu, Meng; Jiang, Xiaohui; Keire, David; Boyne II, Michael
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In Vitro Tests for Aerosol Deposition. IV: Simulating Variations in Human Breath Profiles for Realistic DPI Testing
Delvadia, Renishkumar; Wei, Xiangyin; Longest, Worth; Venitz, Jurgen; Byron, Peter