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 Generic Perspective On The Use Of In Vitro Assessment Methods

  Raney, Sam

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

  Raney, Sam

• Facilitating Patient Access to High-Quality Generic Transdermal Products: The Role of FDA and GDUFA

  Raney, Sam

• Overview of Current Science Based Regulatory Standards

  Raney, Sam

• FDA Champions Research to Make Complex Generic Transdermal Products Available to Patients

  Raney, Sam

• FDA Regulatory Initiatives Related to Generic Dermatological and Transdermal Drug Products

  Raney, Sam

• Novel Approaches for Evaluating Bioavailability and Bioequivalence (BE) of Topical Drug Products

  Ramezanli, Tannaz

• In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches

  Ramezanli, Tannaz

• Best Practices & Efficient Strategies for Generic Topical Product Development

  Ramezanli, Tannaz

• How to Structure Efficient Development Programs for Generic Topical Drug Products

  Ramezanli, Tannaz