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)

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products

  Conti, Denise

• Considerations for Pre-ANDA Meeting Requests for Orally Inhaled and Nasal Drug Products

  Conti, Denise

• Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products

  Conti, Denise

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products

  Conti, Denise

• Current Product-specific Guidances and Common Questions in Pre-ANDA Communications

  Conti, Denise

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

  Conti, Denise

• Post-Approval Impact of Generic Fluticasone Propionate & Salmeterol Inhalation Powder

  Clerman, Andrew

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled Drug Products

  Clerman, Andrew

• Novel Method for Aerodynamic Particle Size Distribution Measurements from Respimat Inhalers

  Chopski, Steven; Hu, Meng; Walenga, Ross; Boc, Susan; Newman, Bryan; Kakhi, Maziar; Zhao, Liang; Guha, Suvajyoti

• 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