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(136)
• Posters(22)
• Presentations(67)
• Papers(47)

• Effect of Spray Momentum on Nasal Spray Droplet Transport and Deposition

  Kolanjiyil, Arun; Manniello, Michele; Alfaifi, Ali; Farkas, Dale; Hosseini, Sana; Hindle, Michael; Golshahi, Laleh; Longest, Worth

• The Effects of Inhalation Flow Rate on Aerodynamic Particle Size Distribution of Commercial Solution and Suspension Metered Dose Inhalers

  Mohan, AR; Dhapare, S; Newman, B; Svensson, M; Elfman, P; Winner, L; Bulitta, JB; Hochhaus, G

• Measurement of Drug in Small Particles from Aqueous Nasal Sprays by Andersen Cascade Impactor

  Doub, William; Adams, Wallace; Wokovich, Anna; Black, John; Shen, Meiyu; Buhse, Lucinda

• A Physiologically-Based Pharmacokinetic Model Framework To Estimate Systemic Bioavailability Of Fluticasone Propionate Nasal Spray

  Schroeter, Jeffry; Stricklin, David; Kimbell, Julia; Delvadia, Renishkumar

• In Vitro Evaluation of Regional Nasal Drug Delivery Using Multiple Anatomical Nasal Replicas of Adult Human Subjects and Two Nasal Sprays

  Manniello, Michele; Hosseini, Sana; Alfaifi, Ali; Esmaeili, Amir; Kolanjiyil, Arun; Walenga, Ross; Babiskin, Andrew; Sandell, Dennis; Mohammadi, Reza; Schuman, Theodore; Hindle, Michael; Golshahi, Laleh

• Importance of Cloud Motion and Two-way Momentum Coupling in the Transport of Pharmaceutical Nasal Sprays

  Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Hindle, Michael; Golshahi, Laleh; Longest, Worth

• Anatomically Realistic Nasal Replicas Capturing the Range of Nasal Spray Drug Delivery in Adults

  Alfaifi, A; Hosseini, S; Esmaeili, A; Walenga, R; Babiskin, A; Schuman, T; Longest, W; Hindle, M; Golshahi, L

• Session 4: Computational Models to Understand In Vivo Performance of OINDPs

  Liang, Zhao

• Opeing Remarks

  Zhang, Lei

• Generic Drug Development For Respiratory Products, US Food And Drug Administration Update

  Newman, Bryan