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)

• Anatomically-Detailed Segmented Representative Adult and Pediatric Nasal Models for Assessing Regional Drug Delivery and Bioequivalence with Suspension Nasal Sprays

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

• 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

• Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate

  Walenga, Ross; Tsakalozou, Eleftheria; Chopski, Steven; Fang, L; Zhao, Liang

• In Vitro Evaluation of Intersubject Variability in Pediatric Intranasal Drug Delivery using Nasal Spray Suspension Products

  Esmaeili, Amir; Wilkins, John; Hosseini, Sana; Alfaifi, Ali; Hejazi, Mohammed; Hindle, Michael; Longest, Worth; Schuman, Theodore; Dhapare, Sneha; Kaviratna, Anubhav; Walenga, Ross; Newman, Bryan; Golshahi, Laleh

• iBCS: 3. A Biopharmaceutics Classification System for Orally Inhaled Drug Products

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

• Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease

  Clerman, Andrew; Luke, Markham

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

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

• Nasal Steroid Spray Simulations Using Measured Spray Characteristics in Healthy and Rhinitic Nasal Passages

  Kimbell, J S; Garcia, G J M; Schroeter, J D; Sheth, P; Vallorz-III, E L; Saluja, B; Babiskin, A H; Tian, G; Walenga, R L

• Transport and Deposition of Beclomethasone Dipropionate Drug Aerosols with Varying Ethanol Concentration in Severe Asthmatic Subjects

  Rajaraman, Prathish; Choi, Jiwoong; Babiskin, Andrew; Walenga, Ross; Lin, Chinglong

• Sensitivity of Pharmacokinetics to Differences in the Particle Size Distribution for Formulations of Locally Acting Mometasone Furoate Suspension-Based Nasal Sprays

  Amini, Elham; Berger, Simon; Schilling, U; Jiao, Y; Chen, M J; Bachhav, Sagar; Baumstein, S; Tang, Y; Al-Humiari, M; Leon Astudillo, C; Drescher, S; Iley, T; Shur, J; Price, R; Carrasco, Cynthia; Conti, Denise; Delvadia, RR; Oguntimein, O; Witzmann, Kim; Absar, M; Luke, Markham; Boc, Susan; Dhapare, S; Saluja, B; Bielski, Elizabeth; Newman, Bryan; Bulitta, J; Hochhaus, G