GDUFA Research Outcomes

Inhalation Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the inhalation route, including orally inhaled products.

• All(283)
• Posters(52)
• Presentations(126)
• Papers(105)

• Characterization of Spray-dried Phospholipid Porous Particles for Inhalation Drug Delivery

  Wanasathop, Apipa; Sonju, Jafrin Jobayer; Boc, Susan; Mohan, Abhinav R; Dhapare, Sneha; Bielski, Elizabeth; Newman, Bryan; Ashraf, Muhammad; Xu, Xiaoming; Yang, Yang

• 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

• The Role of Capsule Aperture Size on the Dispersion of Carrier-based Formulation at Different Air Flowrates

  Tang, Patricia; Kakhi, Maziar; Albariqi, Ahmed; Behara, Srinivas; Walenga, Ross; Yang, Runyu; Chan, Hak-Kim

• 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

• Establishing Quantitative Relationships Between Changes in Nasal Spray In Vitro Metrics and Drug Delivery to the Posterior Nasal Region

  Kolanjiyil, AV; Walenga, Ross; Babiskin, Andrew; Golshahi, L; Hindle, Michael; Longest, Worth

• Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development

  Mohan, Abhinav; Wang, Qiang; Dhapare, Sneha; Bielski, Elizabeth; Kaviratna, Anubhav; Han, Liangfeng; Boc, Susan; Newman, Bryan

• An Effective PBPK Model Predicting Dissolved Drug Transfer from a Representative Nasal Cavity to the Blood Stream

  Dave, Sujal; Kleinstreuer, Clement; Chari, Sriram

• Effect of Inflow Conditioning for Dry Powder Inhalers

  Singh, Gajendra; Lowe, Albyn; Azeem, Athiya; Cheng, Shaokoon; Chan, Hak-Kim; Walenga, Ross; Kourmatzis, Agisilaos

• Automated Classification of Dry Powder Inhaler Agglomerate Particles Using Cluster Analysis and Morphologically-directed Raman Spectroscopy

  Ganley, William; Paddock, Alice; Farias, Goncalo; Penas, Abel Garcia; Shur, Jagdeep; Price, Robert

• Development of a Stochastic Individual Path (SIP) Model for Predicting the Tracheobronchial Deposition of Pharmaceutical Aerosols: Effects of Transient Inhalation and Sampling the Airways

  Tian, Geng; Longest, Worth; Su, Guoguang; Walenga, Ross; Hindle, Michael