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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Overview of Complex Generic Orally Inhaled Drug Products
Newman, Bryan
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Overview of Complex Generic Inhalation and Nasal Drug-Device Combination Products
Newman, Bryan
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PSG Recommendations and Updates for OINDPs
Newman, Bryan
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The Effects of Inhalation Flow Rate on Aerodynamic Particle Size Distribution of Commercial Solution and Suspension Metered Dose Inhalers (MDIs)
Mohan, Abhinav
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Bioequivalence Considerations for Conducting Bridging Studies with Orally Inhaled and Nasal Drug Products
Ma, Tian
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Generic Drug Development For Respiratory Products, US Food And Drug Administration Update
Luke, Markham; Witzmann, Kimberly; Conti, Denise
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Generic Drug Development For Respiratory Products, US Food And Drug Administration Update
Luke, Markham; Witzmann, Kimberly; Conti, Denise
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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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Session 3: Realistic Models for Prediction of Regional Drug Deposition from Orally Inhaled and Nasal Drug Products (OINDPs)
Luke, Markham