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.

• All(117)
• Posters(35)
• Presentations(61)
• Papers(21)

• A Fully Validated LC-MSMS Method for Simultaneous Determination of Nicotine its Metabolite Cotinine in Human Serum its Application to a Pharmacokinetic Study after Using Nicotine Transdermal Delivery Systems with Stard Heat Application in Adult Smokers

  Abdallaha, Inas; Hammell, Dana; Stinchcomb, Audra; Hassan, Hazem

• Identification of Non-Reported Bupropion Metabolites in Human Plasma

  Connarn, Jamie; Luo, Ruijuan; Windak, Jim; Zhang, Xinyuan; Babiskin, Andrew; Kelly, Marisa; Harrington, Gloria; Ellingrod, Vicki; Kamali, Masoud; Mcinnis, Melvin; Sun, Duxin

• Modeling Temperature-Dependent Dermal Absorption and Clearance for Transdermal and Topical Drug Applications

  Lacount, Terri; Zhang, Qian; Hao, Jinsong; Ghosh, Priyanka; Raney, Sam; Talattof, Arjang; Kasting, Gerald; Li, Kevin

• Identification of critical formulation parameters affecting the in vitro release, permeation, and rheological properties of the acyclovir topical cream

  Kamal, Nahid; Krishnaiah, Yellela; Xu, Xiaoming; Zidan, Ahmed; Raney, Sam; Cruz, Celia; Ashraf, Muhammad

• In Vitro-In Vivo Correlations for Nicotine Transdermal Delivery Systems Evaluated by both In Vitro Skin Permeation (IVPT) and In Vivo Serum Pharmacokinetics under the Influence of Transient Heat Application

  Shin, Soo Hyeon; Thomas, Sherin; Raney, Sam; Ghosh, Priyanka; Hammell, Dana; El Kamary, Samer; Chen, Wilbur; Billington, Melissa; Hassan, Hazem; Stinchcomb, Audra

• Determination of Rate and Extent of Scopolamine Release from Transderm Scop� Transdermal Drug Delivery Systems in Healthy Human Adults

  Swaminathan, Suresh; Strasinger, Caroline; Kelchen, Megan; Carr, Jamie; Ye, Wei; Wokovich, Anna; Ghosh, Priyanka; Rajagopal, Srinivasan; Ueda, Kenichi; Fisher, James; Kandimalla, Karunya; Brogden, Nicole

• Norelgestromin/Ethinyl Estradiol Intravenous Infusion Formulationoptimization; Stability And Compatibility Testing: A Case Study To overcome Polysorbate 80 Interference In Chromatographic Analysis

  Abdallaha, Inas; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra

• Characterization of Temperature Profiles in Skin Transdermal Delivery System When Exposed to Temperature Gradients In Vivo In Vitro

  Zhang, Qian; Murawsky, Michael; Lacount, Terri; Hao, Jinsong; Kasting, Gerald; Newman, Bryan; Ghosh, Priyanka; Raney, Sam; Li, Kevin

• LC-MS Determination of Fentanyl in Human Serum and Application to a Fentanyl Transdermal Delivery Pharmacokinetic Study

  Yu, Mingming; Abdallah, Inas; Shin, Soo Hyeon; Hammell, Dana; Stinchcomb, Audra; Hassan, Hazem

• Effect of Controlled Heat Application on Topical Diclofenac Formulations Evaluated by In Vitro Permeation Tests (Ivpt) using Porcine and Human Skin

  Thomas, Sherin; Shin, Soo Hyeon; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra