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)

• The Effects of Inhalation Flow Rate on Aerodynamic Particle Size Distribution of Commercial Solution and Suspension Metered Dose Inhalers (MDIs)

  Mohan, Abhinav

• Characterizing Deposition Inside an Optically Accessible Dry Powder Inhaler using Optical Coherence Tomography

  Mekonnen, TT; Milton-Mcgurk, L; Cheng, S; Tai, W; Chan, HK; Boc, Susan; Singh, G; Kourmatzis, A

• Bioequivalence Considerations for Conducting Bridging Studies with Orally Inhaled and Nasal Drug Products

  Ma, Tian

• Navigating the Transition to Low Global Warming Potential Propellants

  Luke, Markham C

• Generic Drug Development For Respiratory Products, US Food And Drug Administration Update

  Luke, Markham; Witzmann, Kimberly; Conti, Denise

• Session 3: Realistic Models for Prediction of Regional Drug Deposition from Orally Inhaled and Nasal Drug Products (OINDPs)

  Luke, Markham

• Generic Drug Development For Respiratory Products, US Food And Drug Administration Update

  Luke, Markham; Witzmann, Kimberly; Conti, Denise

• Case Study: Predicting Regional Lung Deposition of Pharmaceutical Aerosols with CFD

  Longest, Worth; Dutta, Rabijit

• Modeling Complex Particle Interactions in Dry Powder Inhaler

  Liu, Xiaoyu; Sulaiman, Mostafa; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran

• New Tools for Generic OIDPs to Maximize Prospects of FDA Approval

  Lionberger, Robert