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)

• Advantages and Challenges in Implementing New Analytical Methods that Arise from Regulatry Science Initiatives

  Kozak, Darby

• Advantages and Challenges in Implementing New Analytical Methods that Arise from Regulatry Science Initiatives

  Kozak, Darby

• An FDA Perspective on the Comparative Analyses of Critical Material, Quality, and Design Attributes for Topical, Transdermal, Rectal, and Vaginal Drug-Device Combination Products

  Kelchen, Megan

• Bioequivalence Evaluation of Narrow Therapeutic Index Drugs – Rationales for the Current Regulatory Approach by U.S. FDA

  Jiang, Wenlei

• U.S. FDA Recommendation on Bioequivalence Demonstration of Topical Drug Products

  Jiang, Wenlei

• Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches

  Ghosh, Priyanka

• Bioequivalence of Generic Topical Dermatological Drug Products

  Ghosh, Priyanka; Luke, Markham; Tsakalozou, Eleftheria; Simamora, Pahala

• Innovation and Harmonization of Bioequivalence Standards for Generic Topical and Transdermal Products

  Ghosh, Priyanka

• Bioequivalence Fundamentals for Generic Topical Dermatological Drug Products

  Ghosh, Priyanka

• FDA Initiatives to Stimulate Innovation and Imporve Patient Access to Generic Topical & Transdermal Products Part lI

  Ghosh, Priyanka