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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Impact of the Statistical Approach in the United States Food and Drug Administration (US FDA)’s 2016 Draft Guidance on Assessing Adhesion with Transdermal Delivery Systems (TDS) for Abbreviated New Drug Applications (ANDAs)
Sun, Wanjie; Grosser, Stella; Kim, Carol; Raney, Sam
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A Comparison of the European Medicines Agency (EMA) and United States Food and Drug Administration Approaches to Assessing/Comparing In Vivo Adhesion for Transdermal Delivery Systems (TDS)
Sun, Wanjie; Grosser, Stella; Kim, Carol; Raney, Sam
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Statistical Considerations in OGD’s New Draft Guidance for Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs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