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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Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products
Li, Matt (Zhichuan)
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In Silico Study of the Effect of Including Lactose Fines in Modeling Dry Powder Inhaler Performance
Lee, Jae
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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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Generic Drug User Fee Amendments (GDUFA) Research and the Product-Specific Guidance (PSG) Program for Complex Products: Challenges and Notable Advances
Kozak, Darby
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Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods
Kozak, Darby
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Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness
Kozak, Darby
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Laser and Optical Diagnostics for Characterization of DPIs
Kourmatzis, A
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On the Importance of Liquid Motion in Nasal Spray Delivery
Kolanjiyil, A; Golshahi, L; Longest, W
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Optical Photothermal Infrared Spectroscopic Assessment of Fluticasone/Salmeterol/Lactose Co-Association in Advair Diskus 100/50 and Wixela Inhub 100/50
Khanal, Dipesh; Haque, Sheikh Tanzina; Joseph, Blessy; Bielski, Elizabeth; Newman, Bryan; Yilmaz, Huzeyfe; Ahmed, Snober; Boc, Susan; Chan, Hak Kim; Holl, Mark Banaszak
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Assessment of Fluticasone Propionate/Salmeterol Xinafoate/Lactose Particle Sizes and Co-Associations in Pharmaceutical Dry Powder Inhalation Products: A Photothermal Nanospectroscopic Study
Khanal, Dipesh; Haque, Sheikh Tanzina; Joseph, Blessy; Bielski, Elizabeth; Newman, Bryan; Yilmaz, Huzeyfe; Ahmed, Snober; Boc, Susan; Chan, Hak-Kim; Holl Banaszak, Mark