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)

• Effects of Subject-Variability on Nasally Inhaled Drug Deposition, Uptake, and Clearance

  Chari, Sriram; Sridhar, Karthik; Kleinstreuer, Clement

• Systematic Evaluation of the Effect of Formulation Variables on In Vitro Performance of Mometasone Furoate Suspension-Metered Dose Inhalers

  Bachhav, Sagar; Sheth, Poonam; Sandell, Dennis; Svensson, Marten; Bhagwat, Sharvari; Conti, Denise; Oguntimein, Oluwamurewa; Dhapare, Sneha; Saluja, Bhawana; Winner, Lawrence; Bulitta, Jurgen; Hochhaus, Gunther

• A quasi-3D model of the whole lung: airway extension to the tracheobronchial limit using the constrained constructive optimization and alveolar modeling, using a sac–trumpet model

  Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej; Zhou, Xianlian; Walenga, Ross; Babiskin, Andrew

• Application of the Modified chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing

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

• Use of Realistic Testing for Lifecycle Changes: A Proposal for Discussion and Possible Future Regulatory Guidance

  Sandell, Dennis

• A Compartment-Quasi-3D Multiscale Approach for Drug Absorption, Transport, and Retention in the Human Lungs

  Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej

• 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