GDUFA Research Outcomes
Nasal Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the nasal route, including nasal sprays.
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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
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Current Product-specific Guidances and Common Questions in Pre-ANDA Communications
Conti, Denise
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Emerging Technologies for Bioequivalence of Generic Complex Drug-Device Combination Products
Conti, Denise
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Scientific Careers at FDA: Where Science Meets Regulations and Public Health
Bielski, Elizabeth
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Advancements in In Vitro Studies for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies
Bielski, Elizabeth
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Clinically Relevant In Vitro Tests for the Assessment of Innovator and Generic Nasal Spray Products
Azimi, Mandana; Longest, P Worth; Shur, Jag; Price, Robert; Hindle, Michael
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A Physiologically-Based Pharmacokinetic Model to Estimate Absorption and Bioavailability of Corticosteroid Nasal Sprays
Schroeter, J; Rose, M; Kimbell, J; Chopski, S; Walenga, R
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Effect of Polydispersity on PBPK Model Simulations of Intranasal Corticosteroid Sprays
Schroeter, Jeffrey; Rose, Morgan; Kimbell, Julia; Chopski, Steven; Walenga, Ross