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.
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Session 2: Novel Analytical Tools for Characterization of Nasal Suspensions
Jiang, Xiaohui
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From Q2 To Qbd: The Influence Of Formulation Changes On Mdi Performance
Holt, Jay; Hickey, Anthony; Sandell, Dennis
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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
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Using PBPK to Link Systemic PK to Local Delivery in the Lung
Hochhaus, Gunther; Bulitta, Jurgen; Price, Rob; Shur, Jag; Hindle, Mike
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Pharmacokinetic Comparison of Locally Acting Dry Powder Inhalers
Hochhaus, Gunther; Bulitta, Jurgen
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In Vitro Testing – Predictive of In Vivo Performance of OIDPs?
Hochhaus, Gunther
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Dissolution Methods for Orally Inhaled Drug Products
Hochhaus, Gunther
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Development of an Optimized Dissolution Test System for OINDPs
Hochhaus, Gunther
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The Potential of Pharmacokinetic Bioequivalence (BE) Studies in Detecting Regional Deposition with Orally Inhaled Drug Products
Han, Liangfeng
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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