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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• Topical Drug Delivery – Scientific and Regulatory Considerations for Generic Drug Products

  Raney, Sam

• Influence of Physicochemical & Structural Formulation Attributes on Topical Bioavailability

  Raney, Sam G

• Revision to U.S. Pharmacopeia General Chapter <1724> Semisolid Drug Products – Performance Tests In Vitro Permeation Test (IVPT)

  Raney, Sam G.

• Scientific and Regulatory Advances for Complex Generic Topical Products

  Raney, Sam G.

• GDUFA Science and Research Program

  Raney, Sam

• A Regulatory Perspective on Physicochemical, Structural, and Performance Characterization of Topical Semisolid Products

  Raney, Sam

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

  Raney, Sam

• Use of Q3 Characterization Tests for Topical Semisolid Drug Products

  Raney, Sam

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

  Raney, Sam

• In Vitro Permeation Test (IVPT) Fundamentals: Scientific and Practical Considerations

  Raney, Sam