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(217)
• Posters(37)
• Presentations(91)
• Papers(89)

• 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

• Cascade Impactor Equivalence Testing: Comparison of the Performance of the Modified Chi-Square Ratio Statistic (mCSRS) with the Original CSRS and EMA’s Average Bioequivalence Approach

  Kurumaddali, Abhinav; Christopher, David; Sandell, Dennis; Strickland, Helen; Morgan, Beth; Bulitta, Juergen; Wiggerhorn, Christopher; Stein, Stephen; Lyapustina, Svetlana; Hochhaus, Guenther

• Generic Drug Device Combination Products: Regulatory and Scientific Considerations

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

• Predicting Systemic and Pulmonary Tissue Barrier Concentration of Orally Inhaled Drug Products

  Singh, Narender; Kannan, Ravi; Arey, Ryan; Walenga, Ross; Babiskin, Andrew; Przekwas, Andrzej

• Factors Influencing Plume Characteristics of Metered Dose Inhalers (MDIs) Following Passage through Bio-relevant Mouth-Throat Models

  Dhapare, Sneha; Newman, Bryan; Svensson, Marten; Elfman, Peter; Sandell, Dennis; Winner, Larry; Bulitta, Jurgen; Hochhaus, Gunther

• Effects of Formulation Variables on Lung Dosimetry of Albuterol Sulfate Suspension and Beclomethasone Dipropionate Solution Metered Dose Inhalers

  Schroeter, Jeffry; Sheth, Poonam; Hickey, Anthony; Asgharian, Bahman; Price, Owen; Holt, Jay; Conti, Denise; Saluja, Bhawana

• Scientific and Regulatory Activities Initiated by the U.S. Food and Drug Administration to Foster Approvals of Generic Dry Powder Inhalers: Quality Perspective

  El-Gendy, Nashwa; Bertha, Craig M; El-Shafy, Mohammed; Gaglani, Dhaval; Babiskin, Andrew; Bielski, Elizabeth; Boc, Susan; Dhapare, Sneha; Fang, Lanyan(Lucy); Feibus, Karen; Kaviratna, Anubnav; Li, Bing; Luke, Markham C; Ma, Tian; Newman, Bryan; Walenga, Ross; Zhao, Liang