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)

• 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

• 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

• 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

• 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

• 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

• Particle-based coarse-grained approach for simulating dry powder inhaler

  Liu, Xiaoyu; Sulaiman, Mostafa; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran

• 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

• 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

• 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

• The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler In Vitro Aerosolization Performance

  Bielski, Elizabeth