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)

• iBCS: 2. Mechanistic Modeling of Pulmonary Availability of Inhaled Drugs versus Critical Product Attributes

  Backman, Per; Cabal, Antonio; Clark, Andy; Ehrhardt, Carsten; Forbes, Ben; Hastedt, Jayne; Hickey, Anthony; Hochhaus, Guenther; Jiang, Wenlei; Kassinos, Stavros; Kuehl, Philip J; Prime, David; Son, Yoen-Ju; Teague, Simon P; Tehler, Ulrika; Wylie, Jennifer

• Validating Whole-Airway CFD Predictions of DPI Aerosol Deposition at Multiple Flow Rates

  Longest, Worth; Tian, Geng; Khajeh Hosseini Dalasm, Nawab; Hindle, Michael

• Importance of Spray-Wall Interaction and Post-Deposition Liquid Motion in the Transport and Delivery of Pharmaceutical Nasal Sprays

  Kolanjiyil, Arun V; Alfaifi, Ali; Aladwani, Ghali; Golshahi, Laleh; Longest, Worth

• In Silico Models of Aerosol Delivery to the Respiratory Tract – Development and Applications

  Holbrook, Landon

• Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products

  Witzmann, Kimberly

• A Sensitivity Analysis of the Modified Chi-Square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution

  Weber, Benjamin; Lee, Sau; Lionberger, Robert; Li, Bing; Tsong, Yi; Hochhaus, Guenther

• 1D Network Simulations for Evaluating Regional Flow and Pressure Distributions in Healthy and Asthmatic Human Lungs

  Choi, Sanghun; Yoon, Sujin; Jeon, Jichan; Zou, Chunrui; Choi, Jiwoong; Tawhai, Merryn; Hoffman, Eric; Delvadia, Renishkumar; Babiskin, Andrew; Walenga, Ross; Lin, Chinglong

• Predicting Pulmonary Pharmacokinetics from In Vitro Properties of Dry Powder Inhalers

  Bhagwat, Sharvari; Schilling, Uta; Chen, Mongjen; Wei, Xiangyin; Delvadia, Renishkumar; Absar, Mohammad; Saluja, Bhawana; Hochhaus, Guenther

• Effect of an Upstream Grid on the Fluidization of Pharmaceutical Carrier Powders

  Elserfy, Khalid; Kourmatzis, Agisilaos; Chan, Hak Kim; Walenga, Ross; Cheng, Shaokoon

• Assessment and Validation of a Hygroscopic Growth Model with Different Water Activity Estimation Methods

  O’shaughnessy, Patrick; Leblanc, Lawrence; Pratt, Alessandra; Altmaier, Ralph; Rajaraman, Prathish; Walenga, Ross; Lin, Chinglong