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)

• Bioequivalence Testing: Can Systemic Pharmacokinetic Profiles From Corticosteroid Nasal Sprays Be Used To Elucidate Local Drug Deposition Within The Nose?

  Longest, Worth; Rygg, Alex; Hindle, Michael

• New Tools for Generic OIDPs to Maximize Prospects of FDA Approval

  Lionberger, Robert

• Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products

  Li, Matt (Zhichuan)

• Laser and Optical Diagnostics for Characterization of DPIs

  Kourmatzis, A

• Session 2: Novel Analytical Tools for Characterization of Nasal Suspensions

  Jiang, Xiaohui

• Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders

  Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, Changning

• Alternative Bioequivalence Approach Using Morphologically-Directed Raman Spectroscopy (MDRS) on Nasal Spray Suspensions

  Holtgrewe, N

• Evaluating Particle Size Differences of Suspension-based Nasal Sprays Through In Vitro and Pharmacokinetic Approaches

  Hochhaus, G; Amini, E; Berger, S; Shur, J; Kurumaddali, A; Schilling, U; Jiao, Y; Drescher, S; Seay, B; Baumstein, S; Abu Hasan, M; Oguntimein, O; Carrasco, C; Winner, L; Delvadia, R; Saluja, B; Price, R; Conti, D; Dhapare, S; Newman, B; Bulitta, J

• Pharmacokinetic Comparison of Locally Acting Nasal Suspension Spray Products

  Hochhaus, Gunther; Bulitta, Jurgen

• Comparing Nasal Suspension Products Using Realistic In Vitro Test Methods

  Hindle, Mike