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 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

• Absorption and Clearance of Pharmaceutical Aerosols in the Human Nose: Effects of Nasal Spray Suspension Particle Size and Properties

  Rygg, Alex; Hindle, Michael; Longest, Worth

• Validating CFD Predictions of Nasal Spray Deposition: Inclusion of Cloud Motion Effects for Two Spray Pump Designs

  Kolanjiyil, Arun V; Hosseini, Sana; Alfaifi, Ali; Farkas, Dale; Walenga, Ross; Babiskin, Andrew; Hindle, Michael; Golshahi, Laleh; Longest, P Worth

• iBCS: 2. Mechanistic Modeling of Pulmonary Availability of Inhaled Drugs versus Critical Product Attributes

  Backman, Per; Cabal, Antonio; Clark, Andy; Ehrhardt, Carsten; Forbes, Ben; Hastedt, Jayne; Hickey, Anthony; Hochhaus, Guenther; Jiang, Wenlei; Kassinos, Stavros; Kuehl, Philip J; Prime, David; Son, Yoen-Ju; Teague, Simon P; Tehler, Ulrika; Wylie, Jennifer

• Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products

  Lionberger, Robert

• Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective

  Liu, Qing; Absar, Mohammad; Saluja, Bhawana; Guo, Changning; Chowdhury, Badrul; Lionberger, Robert; Conner, Dale; Li, Bing

• Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval

  Li, Bing; Jin, Feiyan; Lee, Sau; Bai, Tao; Chowdhury, Badrul; Caramenico, Hoainhon; Conner, Dale

• Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products

  Witzmann, Kimberly

• Clinically Relevant In Vitro Tests for the Assessment of Innovator and Generic Nasal Spray Products

  Azimi, Mandana; Longest, Worth; Shur, Jagdeep; Price, Robert; Hindle, Michael