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)

• Mathematical Models of Skin Penetration

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Drug Permeation through Skin: A Challenging Application for High Performance Scientific Computing

  Heisig, M; Nagel, A; Wittum, G

• Use of Skin Pharmacokinetics (PK) & Pharmacodynamics (PD) in Drug Development

  Sinner, Frank

• Dermatopharmacokinetics: Modelling, Assessment and Optimization

  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

• Assessing Topical Drug Bioavailability in the Skin Using Raman Spectroscopy

  Tabosa, Alice

• Bioequivalence of Generic Topical Dermatological Drug Products

  Ghosh, Priyanka; Luke, Markham; Tsakalozou, Eleftheria; Simamora, Pahala

• Characterization Based Approaches for Establishing Bioequivalence Locally Acting Drug Products Applied to the Skin

  Ghosh, Priyanka; Luke, Markham

• GDUFA Science and Research Collaborating with the FDA Research Program

  Ghosh, Priyanka