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)

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products

  Bielski, Elizabeth

• Scientific Careers at FDA: Where Science Meets Regulations and Public Health

  Bielski, Elizabeth

• Advancements in In Vitro Studies for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies

  Bielski, Elizabeth

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

  Azimi, Mandana; Longest, P Worth; Shur, Jag; Price, Robert; Hindle, Michael

• In Silico Predictive Modeling of the Pharmacokinetic (PK) Profiles of Nasal Sprays in Adults and Children

  Kaviratna, Anubhav; Mohan, Abhinav R; Newman, Bryan; Walenga, Ross; Dutta, Rabijit; Kolanjiyil, Arun; Longest, P Worth; Golshahi, Laleh

• Understanding the Relationship Between In Vitro Nasal Spray Characteristics and Intranasal Deposition in the Adult and Pediatric Populations

  Hejazi, Mohammed; Khadka, Prakash; Esmaeili, AR; Schuman, Theodore; Kaviratna, Anubhav; Newman, Bryan; Walenga, Ross; Hindle, Michael; Longest, Worth; Golshahi, Laleh

• A Hybrid CFD-PBPK Approach to Simulate Deposition, Absorption, and Bioavailability of Corticosteroid Nasal Sprays

  Schroeter, Jeffry; Garcia, Guilherme; Rose, Morgan; Kimbell, Julia; Walenga, Ross

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

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

• Understanding the Impact of Disease on Pediatric Regional Intranasal Drug Delivery with Nasal Sprays

  Hejazi, Mohammad; Owen, Xiomara; Wilkins, John; Schuman, Theodore; Hindle, Michael; Longest, Worth; Walenga, Ross; Kaviratna, Anubhav; Newman, Bryan; Golshahi, Laleh

• Enhanced PBPK-Based In Vitro to In Vivo Extrapolation Method to Support the Development of Pulmonary Drug Products

  Mullin, J M; Le Merdy, Maxime; Chopski, Steven; Walenga, Ross; Bielski, Elizabeth; Boc, Susan; Clerman, Andrew; Newman, Bryan; Pineiro-Llanes, Janny; Eltanameli, Bassma; Cristofoletti, R