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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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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Assessment of Effects of Selective Airway Luminal Expansion on Inhaled Particle Deposition in Severe Asthmatic Human Lungs – A Numerical Study
Choi, Jiwoong; Choi, Sanghun; Hoffman, Eric; O’Shaughenessy, Patrick; Castro, Mario; Delvadia, Renishkumar; Walenga, Ross; Babiskin, Andrew; Lin, Ching-Long
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Characteristics of Inhaled Particle Deposition in the Lungs of Imaging-based Asthma Clusters: a Numerical Study
Choi, J; Leblanc, L; Choi, S; Haghighi, B; Hoffman, E; O’shaughnessy, P; Wenzel, S; Castro, M; Fain, S; Jarjour, N; Schielbler, M; Denlinger, L; Lin, C
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Cluster-guided Imaging-based CFD Analysis of Airflow and Particle Deposition in Asthmatic Human Lungs
Choi, J; Leblanc, L; Choi, S; Haghighi, B; Hoffman, E; Lin, C
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Clinically Relevant In Vitro Testing of Oral Inhalation Products Using Realistic Mouth-Throat Models
Byron, Peter
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Bioequivalence Assessment for Inhalation Products
Byron, P
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Studies to Further Establish PK as Central Tool for a Streamlined Approval of Generic Inhalation Drugs
Bulitta, Jurgen; Hochhaus, Gunther
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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