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.
-
Pharmacokinetics Of Fentanyl After Using Reference And Generic Transdermal Fentanyl Patches With And Without Standardized Heat Application In Healthy Human Volunteers
Yu, Mingming; Shin, Soo Hyeon; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
A Pharmacokinetic Study of Two Oxybutynin Trandermal Formulations with Transient Heat Exposure
Thomas, Sherin; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
A Pharmacokinetic Study of Two Oxybutynin Trandermal Formulations with Transient Heat Exposure
Thomas, Sherin; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
In Vitro and In Vivo Evaluatoin of Two Lidocaine Topical Delivery Systems with or without the Influence of Transient Heat Exposure
Thomas, Sherin; Shukla, Sagar; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
In Vitro Evaluation of a Buprenorphine Transdermal Delivery System with Transient Heat Exposure and the Correlation of In Vitro Results with Existing In Vivo Results
Thomas, Sherin; Ghosh, Priyanka; Raney, Sam; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
In Vitro Evaluation of a Buprenorphine Transdermal Delivery System with Transient Heat Exposure and the Correlation of In Vitro Results with Existing In Vivo Results
Thomas, Sherin; Ghosh, Priyanka; Raney, Sam; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
-
A Pharmacokinetic Study of the Effect of a Standardized Exposure to Heat on Nicotine Transdermal Delivery in Adult Smokers
Thomas, Sherin; Shin, Soo Hyeon; Abdallah, Inas; Ghosh, Priyanka; Newman, Bryan; Raney, Sam; Hammell, Dana; El-Kamary, Samer; Chen, Wilbur; Hassan, Hazem; Stinchcomb, Audra
-
Effect of Adhesion on Pharmacokinetics (PK) of Transdermal (TDS) Topical Products
Sun, Wanjie; Zhang, Zhen; Zhou, Lingjie; Grosser, Stella; Li, Bing; Yim, Sarah; Raney, Sam; Ghosh, Priyanka; Kim, Carol; Wang, Rong
-
Impact of the Statistical Approach in the United States Food and Drug Administration (US FDA)’s 2016 Draft Guidance on Assessing Adhesion with Transdermal Delivery Systems (TDS) for Abbreviated New Drug Applications (ANDAs)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
-
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