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)

• 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

• 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

• 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

• 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

• Session 4: Computational Models to Understand In Vivo Performance of OINDPs

  Liang, Zhao

• Opeing Remarks

  Zhang, Lei

• Characterization of Spray-dried Phospholipid Porous Particles for Inhalation Drug Delivery

  Yang, Yang; Boc, Susan

• Spray-Dried Phospholipid Porous Particles for Inhalation: Effect of Manufacturing Process Parameters on Drug Product Quality

  Yang, Yang

• Effect of the Manufacturing Process Parameters on Critical Quality Attributes of Emerging Spray-Dried Phospholipid Porous Particles for Inhalation Drug Delivery

  Yang, Yang