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)

• Linking Suspension Nasal Spray Drug Deposition Patterns To Pharmacokinetic Profiles: A Proof Of Concept Study Using Computational Fluid Dynamics

  Rygg, Alex; Hindle, Michael; Longest, Worth

• 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, SK; Seay, B; Baumstein, SM; Abu Hasan, MN; Oguntimein, O; Carrasco, C; Winner, L; Delvadia, RR; Saluja, B; Price, R; Conti, DS; Dhapare, S; Newman, B; Bulitta, JB

• Generic Drug Device Combination Products: Regulatory and Scientific Considerations

  Choi, Stephanie; Wang, Yan; Conti, Denise; Raney, Sam; Delvadia, Renishkumar; Leboeuf, Andrew; Witzmann, Kimberly

• Towards clinically relevant in vitro testing of locally acting nasal spray suspension products

  Azimi, Mandana; Longest, Worth; Hindle, Michael

• The Impact of Actuation Force on Droplet Size Distribution Spray Duration of Three Commercially Available Nasal Sprays

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

• In Silico and Experimental Methods to Support Generic Nasal Drug Product (NDP) Development

  Walenga, Ross; Dhapare, Sneha; Newman, Bryan; Babiskin, Andrew; Zhao, Liang

• iBCS: 1. Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System

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

• Computational Analysis of a 3D Mucociliary Clearance Model Predicting Nasal Drug Uptake

  Chari, Sriram; Sridhar, Karthik; Walenga, Ross; Kleinstreuer, Clement

• Analytical Method Development for Characterizing Ingredient-Specific Particle Size Distributions of Nasal Spray Suspension Productsset facetvaluestring

  Thomas, Brandon; Absar, Mohammad; Delvadia, Renishkumar; Conti, Denise; Witzmann, Kimberly; Guo, Changning

• 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