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.
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Statistical Considerations in OGD’s New Draft Guidance for Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs
Sun, Wanjie; Grosser, Stella; Kim, Carol; Raney, Sam
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Impact of Operator Variability on the Reproducibility of Tape Stripping Results
Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra
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In Vivo Evaluation of Lidocaine Bioavailability from Two Topical Patch Products by Pharmacokinetic and Skin (Tape) Stripping Analyses
Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra
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Evaluation Of Two Lidocaine Topical Patch 5% Products By Cutaneous Pharmacokinetic Methods: In Vitro Tape Stripping And In Vitro Permeation Testing
Shukla, Sagar; Raney, Sameersingh; Ghosh, Priyanka; Hassan, Hazem; Bunge, Annette; Stinchcomb, Audra
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Evaluation of Level A In Vitro-In Vivo Correlations (IVIVC) for Nicotine and Fentanyl Transdermal Delivery Systems with Transient Heat Exposure by Using Multiple Approaches
Shin, Soohyeon; Yu, Mingming; Thomas, Sherin; Hammell, Dana; Ghosh, Priyanka; Raney, Sameersingh; Hassan, Hazem; Stinchcomb, Audra
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Evaluation of Level A In Vitro In Vivo Correlations (IVIVC) for Nicotine and Fentanyl Transdermal Delivery Systems
Shin, Soohyeon; Yu, Mingming; Thomas, Sherin; Hammell, Dana; Ghosh, Priyanka; Raney, Sameersingh; Hassan, Hazem; Stinchcomb, Audra
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Level A In Vitro/In Vivo Correlations (IVIVC) for Nicotine and Fentanyl Transdermal Delivery Systems with Transient Heat Exposure, Evaluated using Multiple Approaches
Shin, Soohyeon; Yu, Mingming; Thomas, Sherin; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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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
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Effect Of Heat On Nicotine And Fentanyl Transdermal Delivery Evaluated In Vitro Using Different Skin/Membranes
Shin, Soohyeon; Ghosh, Priyanka; Raney, Sameersingh; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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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, Sameersingh; Ghosh, Priyanka; Newman, Bryan; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra