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)

• 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

• In Vitro Data Analysis Issues: IVPT Analyses and Other Challenges

  Ghosh, Priyanka

• Product Development Considerations for Generic Topical Products

  Ghosh, Priyanka

• Understanding the Complexity of Topical (Dermatological) Semisolids

  Ghosh, Priyanka

• ANDA Challenges Related to Vasoconstrictor Studies

  Feng, Kairui

• ANDA Challenges Related to Vasoconstrictor Studies

  Feng, Kairui

• Symposium 14: Applying Pharmacometrics to Precision Dosing in the Lifecycle of Long-acting Injectable Products: Drug Development, Regulatory Approval & Clinical Practice

  Fang, Lanyan