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)

• Development of a CFD-PK Nasal Spray Model with In Vivo Human Subject Validation

  Dutta, R; Kolanjiyil, AV; Golshahi, L; Longest, P

• In Vitro Tests for Aerosol Deposition V: Using Realistic Testing to Estimate Variations in Aerosol Properties at the Trachea

  Wei, Xiangyin; Hindle, Michael; Delvadia, Renishkumar; Byron, Peter

• Transport and Deposition of Hygroscopic Particles in Asthmatic Subjects with and without Airway Narrowing

  Rajaraman, Prathish; Choi, Jiwoong; Hoffman, Eric; O’shaughnessy, Patrick; Choi, Sanghun; Delvadia, Renishkumar; Babiskin, Andrew; Walenga, Ross; Lin, Chinglong

• Validating CFD Predictions of Highly Localized Aerosol Deposition in Airway Models: In Vitro Data and Effects of Surface Properties

  Longest, Worth

• 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

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

  Chari, Sriram; Sridhar, Karthik; Kleinstreuer, Clement

• 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