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(374)
• Posters(145)
• Presentations(185)
• Papers(44)

• Why Do We Call Excipients in Topical Products Inactive Ingredients?

  Raney, Sam

• Dosage Form And Function: Bioavailability And Bioequivalence Implications For Topical Dermatological Products

  Raney, Sam

• The Matter Of Medicine-Does Form Follow Function Or Vice Versa?

  Raney, Sam

• Considerations Relating To Product Quality Characterization For Topical Semisolid Dosage Forms

  Raney, Sam

• Developing Regulatory Standards for Characterizing Critical Quality Attributes and Performance Attributes for Topical Semisolid Dosage Forms

  Raney, Sam

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

  Ramezanli, Tannaz

• IVRT Method Development, Validation, and Transfer Theoretical Principles and Practical Challenges

  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