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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Abbreviated New Drug Application (ANDA) and Pre-ANDA Experience with Orally Inhaled Drug Product (OIDP) Modeling
Walenga, Ross
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Development of a CFD PK Nasal Spray Model with In Vivo Human Subject Validation
Dytta, R; Kolanjiyil, A; Golshahi, L; Longest, W
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Characterizing the time-course of lung absorption via Population Pharmacokinetic Modeling
Drescher, Stephanie
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Demonstrating Bioequivalence with Inhalation Spray Drug Products
Dhapare, Sneha
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Effects of Formulation and Actuator Design on Spray Velocity of Mometasone Furoate Metered Dose Inhalers
Dhapare, S; Murphy, S; Sandell, D; Winner, L; Sheth, P; Hallinger, M; Svensson, M; Conti, D S; Oguntimein, O; Bulitta, J B; Hochhaus, G
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GDUFA Regulatory Science Initiatives for Generic Orally Inhaled and Nasal Drug Products
Delvadia, Renishkumar
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Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products
Conti, Denise
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Considerations for Pre-ANDA Meeting Requests for Orally Inhaled and Nasal Drug Products
Conti, Denise
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Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products
Conti, Denise
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Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products
Conti, Denise