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)

• 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

• Bioequivalence Assessment for Inhalation Products

  Byron, P

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

  Byron, Peter

• Feasibility of Predicting Regional Lung Exposure from Systemic Pharmacokinetic (PK) Data of Generic OIDPs via Population PK

  Bulitta, J

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

  Bulitta, Jurgen; Hochhaus, Gunther

• Considerations for Conducting More Realistic Aerodynamic Particle Size Distribution Testing for Orally Inhaled Drug Products

  Boc, Susan

• Alternative BE Approaches and Considerations for Nasal Products

  Boc, S

• Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies

  Boc, Susan