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)

• From Q2 To Qbd: The Influence Of Formulation Changes On Mdi Performance

  Holt, Jay; Hickey, Anthony; Sandell, Dennis

• 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

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

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

• Pharmacokinetic Comparison of Locally Acting Dry Powder Inhalers

  Hochhaus, Gunther; Bulitta, Jurgen

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

  Hochhaus, Gunther

• Dissolution Methods for Orally Inhaled Drug Products

  Hochhaus, Gunther

• Development of an Optimized Dissolution Test System for OINDPs

  Hochhaus, Gunther

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

  Han, Liangfeng

• In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple AnatomicallyCorrect Nasal Airway Models

  Golshahi, L; Manniello, M; Hosseini, S; Alfaifi, A; Schuman, T; Hindle, M; Longest, W; Sandell, D

• Abbreviated New Drug Application (ANDA) and Pre-ANDA Experience with Orally Inhaled Drug Product (OIDP) Modeling

  Walenga, Ross