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)

• Heat Effects on Drug Delivery across Human Skin

  Hao, Jinsong; Ghosh, Priyanka; Li, Kevin; Newman, Bryan; Kasting, Gerald; Raney, Sam

• Navigating Sticky Areas in Transdermal Product Development

  Strasinger, Caroline; Raney, Sam; Tran, Doanh; Ghosh, Priyanka; Newman, Bryan; Bashaw, Edward; Ghosh, Tapash; Shukla, Chinmay

• On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl

  Shin, Soo Hyeon; Ghosh, Priyanka; Newman, Bryan; Hammell, Dana; Raney, Sam; Hassan, Hazem; Stinchcomb, Audra

• Statistical Considerations and Impact of the FDA Draft Guidance for Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs

  Sun, Wanjie; Grosser, Stella; Kim, Carol; Raney, Sam

• Introduction to Q3

  Yu, Lawrence

• Bioequivalence of Topical Products

  Yu, Lawrence

• Comparative Analyses: Device and User Interface Considerations

  Witzmann, Kimberly

• Overview of Regulatory and User-Interface Considerations, and the Role of Comparative Analyses, in Developing a Generic Drug-Device Combination Product in an ANDA

  Witzmann, Kimberly

• The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA

  Witzmann, Kimberly

• Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products

  Witzmann, Kimberly