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)

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

  Roberts, Michael

• Mathematical Modeling of Skin Absorption and Transport: Foundation Lecture

  Roberts, Michael

• Correlation of Physicochemical Characteristics and in Vitro Permeation Tests (IVPT) Results for Acyclovir and Metronidazole Topical Products

  Roberts, Michael

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

  Roberts, Michael

• 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

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

  Rantou, Elena

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

  Rantou, Elena

• GDUFA Science and Research Program

  Raney, Sameersingh

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

  Raney, Sameersingh