GDUFA Research Outcomes

Topical Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the topical route, including topical dermatological products.

• All(452)
• Posters(198)
• Presentations(229)
• Papers(25)

• In Vitro Permeation Testing (IVPT)

  Luke, Markham

• Navigating Formulation Assessment: Considerations for Products that are Not Required to be Q1Q2

  Jiang, Ying

• Current Status and Outstanding Challenges IVPT Studies

  Ghosh, Priyanka

• Diffusion Cell Apparatus: Scientific Principles and Practical Challenges I

  Zidan, Ahmed

• Impact of Material Differences on In Vitro Performance of Clindamycin Phosphate Vaginal Creams

  Yue, Weizhou

• Introduction to Q3

  Yu, Lawrence

• Bioequivalence of Topical Products

  Yu, Lawrence

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

  Wilkin, Jonathan

• Role of GDUFA Research on Resolving Technical and Regulatory Challenges for Complex Generic Drug Development and Approval

  Wang, Yan

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan