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)

• Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate

  Walenga, Ross; Tsakalozou, Eleftheria; Chopski, Steven; Fang, Lanyan; Zhao, Liang

• A Physiologically-Based Pharmacokinetic Model to Estimate Absorption and Bioavailability of Corticosteroid Nasal Sprays

  Schroeter, J; Rose, M; Kimbell, J; Chopski, S; Walenga, R

• Effect of Polydispersity on PBPK Model Simulations of Intranasal Corticosteroid Sprays

  Schroeter, Jeffrey; Rose, Morgan; Kimbell, Julia; Chopski, Steven; Walenga, Ross

• A CFD-PBPK Model to Simulate Nasal Absorption and Systemic Bioavailability of Intranasal Fluticasone Propionate

  Schroeter, Jeffry; Kimbell, Julia; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar

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

  Schroeter, Jeffry; Stricklin, Daniela; Kimbell, Julia; Delvadia, Renishkumar; Zhang, Xinyuan

• The Impact Of Actuation Force On Droplet Size Distribution And Spray Duration Of Three Commercially Available Nasal Sprays

  Schroeter, Jeffry; Kimbell, Julia; Saluja, Bhawana; Delvadia, Renishkumar; Vallorz-III, Ernest; Sheth, Poonam

• In Vitro Investigation of Regional Nasal Drug Delivery using Two Glucocorticoid Nasal Spray Products and Twenty Anatomical Nasal Replicas

  Manniello, Michele; Hosseini, Sana; Hindle, Michael; Schuman, Theodore; Longest, Worth; Sandell, Dennis; Golshahi, Laleh

• How Spray Metric Variability Impacts the Initial Deposition of Nasal Sprays

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

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

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

• Estimating Size-specific Numbers of Active Pharmaceutical Ingredient Particles in the Regional Deposition of a Nasal Spray

  Kimbell, Julia; Schroeter, Jeffry; Tian, Geng; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar