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)

• Mathematical Modeling of Skin Absorption and Transport: Foundation Lecture

  Roberts, Michael

• Topical Semisolid Drug Product Critical Quality Attributes (Q3 Characterization) with Relevance to Topical Bioequivalence

  Roberts, Michael

• Statistical Considerations in Assessing BE of IVPT Data

  Rantou, Elena

• Using R for Generic Drug Evaluation and SABE R-package for Assessing Bioequivanlence of Topical Dermatological Products

  Rantou, Elena

• Statistical Issues with Aberrant IVRT/IVPT Data- FDA Perspective

  Rantou, Elena

• Special Cases for the Statistical Evaluation of Bioequivalence: An Example of in-Vitro, Skin Permeation Test Data

  Rantou, Elena

• Assessing Bioequivalence of Locally-Acting Generic Products; Statistical Controversies and Arising Issues

  Rantou, Elena

• 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.