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)

• Physicochemical, Structural, and Performance Characterization of Topical Semisolid Products

  Raney, Sam

• In Vitro Release Test (IVRT) Fundamentals: Scientific and Practical Considerations

  Raney, Sam

• Overview of Breakout Session on Topical Drug Products: Workshop on Complex Generic Drug Products (CGDPs)

  Raney, Sam

• When Do Formulation Differences in Topical Dosage Forms Impact Their Function: Emerging Insights and Implications for Bioequivalence Approaches

  Raney, Sam

• Advances in Topical Bioequivalence Assessments: Characterization-Based Approaches

  Raney, Sam

• A Generic Drugs Perspective on the Use of In Vitro Assesment Methods

  Raney, Sam

• Research Activities, Scientific Advances, & Modernization of Bioequivalence Standards for Generic Topical and Transdermal Products

  Raney, Sam

• 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

• Overview of Current Science Based Regulatory Standards

  Raney, Sam