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)

• 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

• 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

• 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

• Opeing Remarks

  Zhang, Lei

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

  Newman, Bryan

• Comparative Analyses: Device and User Interface Considerations

  Witzmann, Kimberly

• Generic Drug Development for Respiratory Products: US Food and Drug Administration Update

  Witzmann, Kimberly

• Critical Importance of Excipients in Generic Product Development- Now and in the Future

  Witzmann, Kimberly