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(111)
• Posters(33)
• Presentations(58)
• Papers(20)

• 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

• The Pursuit of Alternative Methodologies for Demonstrating Bioequivalence for Generic Topical Dermatologic Drug Products

  Wilkin, Jonathan

• 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

• Scientific Challenges for Generic Transdermal Products: Recent Advances and Future Research

  Stinchcomb, Audra

• Characterizing In Vitro Bioavailability of Acyclovir and Metronidazole Topical Products, and In Vitro-In Vivo Correlation Results with Transdermal Systems

  Stinchcomb, Audra