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)

• Prediction, Assessment and Optimisation of Drug Delivery into and through the Skin

  Guy, Richard

• Prediction and Optimization of Drug Delivery into and Through the Skin

  Guy, Richard

• Measuring Drug Concentration in the Skin in Vivo: Techniques and Challenges

  Guy, Richard

• Predicting, Measuring, and Optimising Drug Delivery to the Skin

  Guy, Richard

• Analysis of ANDA Approval and Major Deficiencies – A Case Study with Topical Products

  Ghosh, Priyanka

• Role of Regulatory Science Research Topical Product Development

  Ghosh, Priyanka

• Impact of GDUFA Regulatory Science and Research Program on Topical Product Availability

  Ghosh, Priyanka

• Characterization-Based Bioequivalence Approaches for Topical Products Part 1: Q3 Guidance

  Ghosh, Priyanka

• GDUFA Science and Research Collaborating with the FDA Research Program

  Ghosh, Priyanka

• Visualizing and Quantifying Drugs Dermal Drug Development

  Ghosh, Priyanka