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)

• Session 3: Realistic Models for Prediction of Regional Drug Deposition from Orally Inhaled and Nasal Drug Products (OINDPs)

  Luke, Markham

• Modeling Complex Particle Interactions in Dry Powder Inhaler

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

• New Tools for Generic OIDPs to Maximize Prospects of FDA Approval

  Lionberger, Robert

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

  Liang, Zhao

• Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products

  Li, Matt (Zhichuan)

• Case Study: Predicting Regional Lung Deposition of Pharmaceutical Aerosols with CFD

  Longest, Worth; Dutta, Rabijit

• A Semi-physiological Approach for Evaluating the Sensitivity of Pharmacokinetics to Detect Differences in Regional Lung Deposition of Orally-inhaled Drug Products (OIDPs)

  Kurumaddali, Abhinav

• On the Importance of Liquid Motion in Nasal Spray Delivery

  Kolanjiyil, A; Golshahi, L; Longest, W

• A Multiscale Framework For Computational Inhalation Pharmacology

  Kannan, Ravi; Chen, Z J; Singh, Narendra; Przekwas, Andrzekj; Delvadia, Renishkumar; Tian, Geng

• Prediction of Respimat® Inhaler Spray: Co-Flow Air Behavior

  Kakhi, Maziar