GDUFA Research Outcomes
Transdermal Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the transdermal route, including transdermal delivery systems.
-
In Vitro and In Vivo Evaluation of Three Fentanyl Transdermal Delivery Systems In Conjunction With Transient Heat Exposure
Shin, Soohyeon; Yu, Mingming; Quarterman, Juliana; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
Effect Of Heat On Nicotine And Fentanyl Transdermal Delivery Evaluated In Vitro Using Different Skin/Membranes
Shin, Soohyeon; Ghosh, Priyanka; Raney, Sam; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
In Vitro/In Vivo Correlation (IVIVC) Of Bioavailability from Nicotine Transdermal Drug Delivery Systems under the Influence of Heat
Shin, Soohyeon; Thomas, Sherin; Aballah, Inas; Raney, Sam; Ghosh, Priyanka; Newman, Bryan; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
Evaluation Of Bioavailability And In Vitro/In Vivo Correlation Of Nicotine Transdermal Drug Delivery Systems Under The Influence Of Heat
Shin, Soohyeon; Thomas, Sherin; Aballah, Inas; Raney, Sam; Ghosh, Priyanka; Newman, Bryan; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
Influence of Heat on Reference and Generic Transdermal Drug Delivery Systems
Shin, Soohyeon; Ghosh, Priyanka; Newman, Bryan; Raney, Sam; Hassan, Hazem; Stinchcomb, Audra
-
Developing In Vitro-In Vivo Correlations (IVIVCs) for In Vitro Permeation Test and In Vivo Pharmacokinetic Studies to Evaluate the Effects of Heat on Nicotine Transdermal Delivery Systems
Ramezanli, Tannaz; Ghosh, Priyanka; Zhang, Yi; Luke, Markham; Shin, Soohyeon; Hassan, Hazem; Stinchcomb, Audra; Zhang, Qian; Raney, Sam
-
Skin Temperature Under Transdermal Patch With Heat Application. Poster Presentation
Murawsky, Michael; Zhang, Qinghua; LaCount, Terri; Hao, Jinsong; Newman, Bryan; Ghosh, Priyanka; Raney, Sam; Kasting, Gerald; Li, Kevin
-
An In Vitro Test Method for Evaluating the Effect of Heat on Tdds Performance
Murawsky, Michael; Zhang, Qinghua; LaCount, Terri; Hao, Jinsong; Newman, Bryan; Ghosh, Priyanka; Raney, Sam; Kasting, Gerald; Li, Kevin
-
Computational Model For Estimating The Effect Of Heat On Dermal Clearance In Skin Transport
LaCount, Terri; Li, Kevin; Kasting, Gerald
-
Strategic analysis of the Roadmap for Implementing Characterization-Based Bioequivalence Approaches in Product-Specific Guidances for Generic Topical Dermatological Drug Products
Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam