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.
-
The Development of Predictive Dissolution Methods for Orally Inhaled Drug Products
Shur, Jag
-
Exploring the Relationship between Suspension and Solution MDI Formulation Variables and Predicted Lung Deposition
Schoroeter, Jeffry (should be Schroeter)
-
Prediction II: Computational Fluid Dynamics, as part of a workshop titled Bridging the Gap from Science to Clinical Efficacy: Imaging, Modelling, and Physiology of Aerosols and the Lung
Schoroeter, Jeffry (should be Schroeter)
-
Varying Particle Size And Excipient Levels For Three Mdis: Effects On In-Vitro Performance
Sandell, Dennis
-
Discriminative in Vitro Dissolution Testing for Orally Inhaled Drug Products
Sakagami, Masahiro
-
Development of Enhanced Analytical Tools fo Evaluation of Complex Generic Products
Rodriguez, Jason
-
Enhanced Analytical Tools for Bioequivalence Evaluation of Nasal Spray Drug Products
Rodriguez, Jason
-
Development of Enhanced Analytical Tools for Evaluation of Complex Generic Products
Rodriguez, Jason
-
Dissolution and Beyond: The Use of Advanced Structural Characterization Tool for Demonstrating Pharmaceutical Equivalence of Orally Inhaled Drug Products
Price, Robert
-
Verifying the Hygroscopic Particle Growth Model during the Time Relevant to Lung Inspiration
O’Shaughnessy, Patrick; Altmaier, Ralph; Walenga, Ross; Lin, Ching-Long