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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In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple AnatomicallyCorrect Nasal Airway Models
Golshahi, L; Manniello, M; Hosseini, S; Alfaifi, A; Schuman, T; Hindle, M; Longest, W; Sandell, D
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Leveraging In Vitro Bioequivalence Tests for Locally-Acting Suspension Nasal Sprays with Three Anatomically-Correct Replicas of Human Nasal Airways Representing Intersubject Variability
Golshahi, L; Alfaifi, A; Hosseini, S; Esmaeili, A; Hindle, M; Longest, W; Schuman T
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In Vitro Evaluation of Regional Drug Deposition in Nasal Airways of Children Using Realistic Anatomical Replicas
Esmaeili, A; Hosseini, S; Wilkins, J; Alfaifi, A; Dhapare, S; Walenga, R; Newman, B; Schuman, T; Edwards, D; Longest, W; Hindle, M; Golshahi, L
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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
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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