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)

• Visualizing and Quantifying Drugs Dermal Drug Development

  Ghosh, Priyanka

• Product Development Considerations and Bioequivalence Strategies for Generic Topical Products

  Ghosh, Priyanka

• Overview FDA’s Generic Drug Research Topical Dermatological Drug Products

  Ghosh, Priyanka

• Scientific and Regulatory Considerations on Dermal PBPK Modeling for Virtual Bioequivalence Assessments and Decision-making

  Tsakalozou, Eleftheria

• Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches

  Ghosh, Priyanka

• Innovation and Harmonization of Bioequivalence Standards for Generic Topical and Transdermal Products

  Ghosh, Priyanka

• Bioequivalence Fundamentals for Generic Topical Dermatological Drug Products

  Ghosh, Priyanka

• FDA Initiatives to Stimulate Innovation and Imporve Patient Access to Generic Topical & Transdermal Products Part lI

  Ghosh, Priyanka

• Use of Imaging Techniques in Dermal Drug Development

  Ghosh, Priyanka

• Topical Semisolids-Similarities/Differences Between Products Administered via Different Routes

  Ghosh, Priyanka