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.
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Session 3: Realistic Models for Prediction of Regional Drug Deposition from Orally Inhaled and Nasal Drug Products (OINDPs)
Luke, Markham
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Modeling Complex Particle Interactions in Dry Powder Inhaler
Liu, Xiaoyu; Sulaiman, Mostafa; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran
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New Tools for Generic OIDPs to Maximize Prospects of FDA Approval
Lionberger, Robert
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Session 4: Computational Models to Understand In Vivo Performance of OINDPs
Liang, Zhao
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Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products
Li, Matt (Zhichuan)
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Case Study: Predicting Regional Lung Deposition of Pharmaceutical Aerosols with CFD
Longest, Worth; Dutta, Rabijit
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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
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On the Importance of Liquid Motion in Nasal Spray Delivery
Kolanjiyil, A; Golshahi, L; Longest, W
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A Multiscale Framework For Computational Inhalation Pharmacology
Kannan, Ravi; Chen, Z J; Singh, Narendra; Przekwas, Andrzekj; Delvadia, Renishkumar; Tian, Geng
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Prediction of Respimat® Inhaler Spray: Co-Flow Air Behavior
Kakhi, Maziar