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)

• Emerging Technologies for Bioequivalence of Generic Complex Drug-Device Combination Products

  Conti, Denise

• Assessment of Effects of Selective Airway Luminal Expansion on Inhaled Particle Deposition in Severe Asthmatic Human Lungs – A Numerical Study

  Choi, Jiwoong; Choi, Sanghun; Hoffman, Eric; O’Shaughenessy, Patrick; Castro, Mario; Delvadia, Renishkumar; Walenga, Ross; Babiskin, Andrew; Lin, Ching-Long

• Characteristics of Inhaled Particle Deposition in the Lungs of Imaging-based Asthma Clusters: a Numerical Study

  Choi, J; Leblanc, L; Choi, S; Haghighi, B; Hoffman, E; O’shaughnessy, P; Wenzel, S; Castro, M; Fain, S; Jarjour, N; Schielbler, M; Denlinger, L; Lin, C

• Cluster-guided Imaging-based CFD Analysis of Airflow and Particle Deposition in Asthmatic Human Lungs

  Choi, J; Leblanc, L; Choi, S; Haghighi, B; Hoffman, E; Lin, C

• Clinically Relevant In Vitro Testing of Oral Inhalation Products Using Realistic Mouth-Throat Models

  Byron, Peter

• Bioequivalence Assessment for Inhalation Products

  Byron, P

• Studies to Further Establish PK as Central Tool for a Streamlined Approval of Generic Inhalation Drugs

  Bulitta, Jurgen; Hochhaus, Gunther

• Scientific Careers at FDA: Where Science Meets Regulations and Public Health

  Bielski, Elizabeth

• Advancements in In Vitro Studies for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies

  Bielski, Elizabeth

• Clinically Relevant In Vitro Tests for the Assessment of Innovator and Generic Nasal Spray Products

  Azimi, Mandana; Longest, P Worth; Shur, Jag; Price, Robert; Hindle, Michael