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)

• Dissolution Methods for Orally Inhaled Drug Products

  Hochhaus, Gunther

• In Vitro Testing – Predictive of In Vivo Performance of OIDPs?

  Hochhaus, Gunther

• Pharmacokinetic Comparison of Locally Acting Dry Powder Inhalers

  Hochhaus, Gunther; Bulitta, Jurgen

• Using PBPK to Link Systemic PK to Local Delivery in the Lung

  Hochhaus, Gunther; Bulitta, Jurgen; Price, Rob; Shur, Jag; Hindle, Mike

• Correlating The In Vitro Dissolution Behavior Of Inhalation And Nasal Drug Products With In Vivo Performance: Pitfalls And Potential Solutions Using The Transwell System

  Hochhaus, Guenther

• Development of an Optimized Dissolution Test System for OINDPs

  Hochhaus, Gunther

• Orally Inhaled Drug Product PSGs: General Considerations Using the Alternative Bioequivalence (BE) Approach In Lieu of Comparative Clinical Endpoint (CCEP) BE Study for Suspension-Based Metered Dose Inhalers

  Han, Liangfeng

• Bioequivalence Approaches for Orally Inhaled Drug Products

  Han, Liangfeng; Bielski, Elizabeth; Ma, Tian

• The Potential of Pharmacokinetic Bioequivalence (BE) Studies in Detecting Regional Deposition with Orally Inhaled Drug Products

  Han, Liangfeng

• Considerations for FEV1-based Comparative Clinical Endpoint or Pharmacodynamic Bioequivalence Studies for Orally Inhaled Drug Products

  Gong, Yuqing