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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Evaluation Of Heat Effects On Transdermal Delivery Systems Using An In Vitro Permeation Test (Ivpt) Strategy
Zhang, Q; Murawsky, M K; Lacount, T; Hao, J; Raney, S G; Ghosh, P; Kasting, G; Li, S
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A Fully Validated LC MS/MS Method For Simultaneous Determination Of Oxybutynin And Its Metabolite N-desethyloxybutynin In Human Serum
Yu, Mingming; Thomas, Sherin; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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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
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A Pharmacokinetic Study of Two Oxybutynin Trandermal Formulations with Transient Heat Exposure
Thomas, Sherin; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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A Pharmacokinetic Study of Two Oxybutynin Trandermal Formulations with Transient Heat Exposure
Thomas, Sherin; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra
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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
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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
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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
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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
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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