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)

• A Multiscale Framework For Computational Inhalation Pharmacology

  Kannan, Ravi; Chen, Z J; Singh, Narendra; Przekwas, Andrzekj; Delvadia, Renishkumar; Tian, Geng

• Prediction of Respimat® Inhaler Spray: Co-Flow Air Behavior

  Kakhi, Maziar

• The Use of Atomic Force Microscope-Infrared Spectroscopy to Assess Co-localization of Fluticasone Propionate/Salmeterol Xinafoate/Lactose Monohydrate in Advair Diskus 100/50 and Wixela Inhub 100/50 Formulations

  Joseph, Blessy; Khanal, Dipesh; Bielski, Elizabeth; Newman, Bryan; Yilmaz, Huzeyfe; Ahmed, Snober; Boc, Susan; Chan, Hak Kim

• Global Bioequivalence Requirements for Orally Inhaled Drug Products (OIDPs)

  Jiang, Wenlei

• Session 2: Novel Analytical Tools for Characterization of Nasal Suspensions

  Jiang, Xiaohui

• From Q2 To Qbd: The Influence Of Formulation Changes On Mdi Performance

  Holt, Jay; Hickey, Anthony; Sandell, Dennis

• Alternative Bioequivalence Approach Using Morphologically-Directed Raman Spectroscopy (MDRS) on Nasal Spray Suspensions

  Holtgrewe, N

• Materials for Aerosol Treatment of Disease: New Microscopy for Bioequivalence and Improving Therapeutic Index

  Holl, Mark Banaszak

• Dissolution Methodologies

  Hochhaus, Gunther

• Unraveling the Pulmonary Fate of Fluticasone and Friends: Meeting the Physiologic and Pharmacokinetic Challenge

  Hochhaus, Guenther