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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CGDPs with Drug and Device Consituents: Transdermal Delivery Systems (TDS)
Ghosh, Priyanka
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In Vitro Data Analysis Issues: IVPT Analyses and Other Challenges
Ghosh, Priyanka
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Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products
Conti, Denise
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Irritation and Sensitization Potential of Approved Topical and Transdermal Delivery Systems ��� A Retrospective Study
Russo, Jackson; Jiang, Ying; Ghosh, Priyanka; Luke, Markham C
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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 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