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(302)
• Posters(57)
• Presentations(136)
• Papers(109)

• Challenges with Method Standarization for Inhalation and Nasal Drug Products

  Boc, Susan

• FDA Perspective on MDI Propellant Transitions – from Generic Drug Perspective

  Newman, Bryan

• Considerations for CFD-DEM Predictions of Regional Deposition Following Dry Powder Inhalation Administration

  Lee, Jae(Mike)

• Optical Photothermal Infrared Spectroscopic Assessment of Fluticasone/Salmeterol/Lactose Co-Association in Advair Diskus 100/50 and Wixela Inhub 100/50

  Khanal, Dipesh; Tanzina Haque, Sheik; Joseph, Blessy; Bielski, Elizabeth; Newman, Bryan; Yilmaz, Huzefye; Ahmed, Snober; Boc, Susan; Chan, Hak-Kim; Banaszak Holl, Mark

• Potential of the In Vitro Dissolution Method DissolvIt® to Predict Pharmacokinetic Outcomes

  Malmlof, Maria; Klups, Iwona; Selg, Ewa; Backman, Per; Olsson, Bo; Bielski, Elizabeth; Newman, Bryan; Walenga, Ross; Chopski, Steven; Gerde, Per

• 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

• Effect of Inflammation on Drug Transporter Concentrations in Human Airway Epithelia Measured by Quantitative Targeted Absolute Proteomics

  Fallon, John K.; Cholon, Deborah M.; Boyles, Susan E.; Tiley, Jacqueline B.; Smith, Philip C.; Rao, Gauri; Gentzsch, Martina; Tan, Ming-Liang; Zhao, Liang; and Esther Jr, Charles R

• Refining Regional Deposition Predictions in MDIs: A Comparison of Static and Dynamic ICRP Models

  Shur,Jagdeep; Walenga, Ross L.

• Computational Fluid Dynamics Model Validation of Spray Characteristics from a Suspension-Based Pressurized Metered-Dose Inhaler

  Sul, Bora; Babiskin, Andrew; Walenga, Ross

• Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability

  Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Jogarao