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.

• All(103)
• Posters(15)
• Presentations(53)
• Papers(35)

• Evaluating Particle Size Differences of Suspension-based Nasal Sprays Through In Vitro and Pharmacokinetic Approaches

  Hochhaus, G; Amini, E; Berger, S; Shur, J; Kurumaddali, A; Schilling, U; Jiao, Y; Drescher, S; Seay, B; Baumstein, S; Abu Hasan, M; Oguntimein, O; Carrasco, C; Winner, L; Delvadia, R; Saluja, B; Price, R; Conti, D; Dhapare, S; Newman, B; Bulitta, J

• Comparing Nasal Suspension Products Using Realistic In Vitro Test Methods

  Hindle, Mike

• The Potential of Pharmacokinetic Bioequivalence (BE) Studies in Detecting Regional Deposition with Orally Inhaled Drug Products

  Han, Liangfeng

• Analytical Method Development for Ingredient-Specific Particle Sizing of Nasal Spray Suspensions

  Guo, Changning

• Pathways to Establish Bioequivalence and Facilitate Development of Innovative and Generic Intranasal Drug Delivery Products: In vitro Anatomically Correct Nasal Models

  Golshahi, Laleh

• 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

• 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

• 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

• GDUFA Regulatory Science Initiatives for Generic Orally Inhaled and Nasal Drug Products

  Delvadia, Renishkumar

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products

  Conti, Denise