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(145)
• Posters(23)
• Presentations(72)
• Papers(50)

• Inhaled Aerosol Dosimetry: Models, Implications and Impact. Proceedings of the Conference

  Phalen, R; Asgharian, B; Oberdörster, G; Murray, J; Ritter, D; Benoit, D; Laube, B; Garcia, G; Dzierlenga, M; Golshahi, L; Debjit, K; Su, WC; Hoffman, D; Schroeter, JD; Price, O; Chesnutt, J; Cassee, F; Sayes, C; Kuczaj, A; Oakes, J; McClellan, RO; Yazbeck, C; Xi, J; Schmid, O; Chalupa, D; Wolff, R; Stout, M; Gupta, A; Dey, S; Woo, CG; Bartol, I; Blayac, M; Graffigna, M; Yu, I; Walenga, R; Mate-Kole, EM; Jarabek, AM

• Challenges and Opportunities for Incorporating Physiological Information into Pharmacokinetic Models of Intranasal Drug Delivery to the Brain: A Review of the Current Status and Future Trajectories

  Rezaee, S; Al-Majdoub, ZM; Galetin, A; Rostami-Hodjegan, A; and Ogungbenro, K

• Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products

  Walenga, Ross; Alam, Khondoker; Clarke, James F.; De Backer, J.; Friden, Markus; Hamadeh, Abdullah; Mowli, Jay; Sonti, Sujatha; Spires, Jessica; Tan, Ming-Liang; Musuamba, Flora T; Tsakalozou, Eleftheria

• Recommendations for Demonstrating Bioequivalence of Nasal Sprays: Scientific Thinking and Regulatory Research

  Boc, Susan

• Evaluating Charcoal Block Pharmacokinetics as a Surrogate for Regional Lung Drug Delivery in Orally Inhaled Drug Products

  Walenga, Ross; Feng, Kairui (Kevin); Hu, Meng; Babiskin, Andrew

• Model Integrated Evidence and Model Master File for Developing Orally Inhaled Drug Products

  Walenga, Ross

• Quantitative Studies to Inform PSG Development for Tiotropium Bromide Inhalation Spray, Metered

  Chopski, Steven; Babiskin, Andrew; Newman, Bryan; Dhapare, Sneha; Boc, Susan; Kakhi, Maziar; Walenga, Ross

• Advancing In Silico Methods and Future Opportunities for Understanding Impact of Compositional Differences on Performance

  Walenga, Ross

• Quantitative Studies to Inform PSG Development for Tiotropium Bromide Inhalation Spray, Metered

  Chopski, Steven; Babiskin, Andrew; Newman, Bryan; Dhapare, Sneha; Boc, Susan; Kakhi, Maziar; Walenga, Ross

• CFD-PK Model for Nasal Suspension Sprays: Validation with Human Adult In Vivo Data for Triamcinolone Acetonide

  Dutta, R; Kolanjiyil, AV; Walenga, R; Chopski, S; Kaviratna, Anubhav; Mohan, Abhinav; Newman, Bryan; Golshahi, L; Longest, Worth