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)

• In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple Anatomically-Correct Nasal Airway Models

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

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

  Schroeter, JD; Rose, M; Kimbell, JS; Chopski, S; Walenga, R

• A Systematic Approach in the Development of the Morphologically-Directed Raman Spectroscopy Methodology for Characterizing Nasal Suspension Drug Products

  Farias, Goncalo; Shur, Jagdeep; Price, Robert; Bielski, Elizabeth; Newman, Bryan

• Absorption and Clearance of Pharmaceutical Aerosols in the Human Nose: Development of a CFD Model

  Longest, Worth

• New Tools for Generic Orally Inhaled Drug Products to Maximize Prospects of Food and Drug Administration Approval

  Lionberger, Robert

• Use of anatomically-accurate 3-dimensional nasal airway models of adult human subjects in a novel methodology to identify and evaluate the internal nasal valve

  Hosseini, Sana; Schuman, Theodore; Walenga, Ross; Wilkins Jr, John; Babiskin, Andrew; Golshahi, Laleh

• Comparison of the in Vitro Deposition of Nasonex(R) Nasal Spray Product in Two Realistic Nasal Airway Models

  Azimi, Mandana; Hindle, Michael; Longest, Worth; Walenga, Ross

• Scientific Considerations for Generic Synthetic Salmon Calcitonin Nasal Spray Products

  Lee, Sau; Yu, Lawrence; Cai, Bing; Johnsons, Gibbes; Rosenberg, Amy; Cherney, Barry; Guo, Wei; Raw, Andre

• Effect of Actuation Force on Simulated Regional Nasal Spray Deposition in a Healthy Nasal Cavity

  Kimbell, Julia; Schroeter, Jeffry; Sheth, Poonam; Tian, Geng; Delvadia, Renishkumar; Saluja, Bhawana; Walenga, Ross

• Utility of the Morphologi 4-ID System to Perform Morphologically-directed Raman Spectroscopy Analysis of Nasal Suspension Formulations

  Farias, Goncalo; Penas, Abel Garcia; Marzal, Nuria; Huck-Jones, Debbie; Kippax, Paul; Price, Robert; Shur, Jagdeep