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)

• Dermal Open Flow Microperfusion (Dofm) For The Bioequivalence Assessment Of Topical Products Based On Skin Pk

  Sinner, Frank

• Evaluating Topical Bioavailability In Vivo By Dermal Open Flow Microperfusion And Equivalence By Ivrt

  Sinner, Frank

• Tissue Specific Pk And Pd Enabled By Open Flow Microperfusion: From Bioequivalence To Mechanism Of Drug Action Poc Studies

  Sinner, Frank

• In Vitro Bioequivalence Data for a Topical Product: Chemistry Review Perspective

  Simamora, Pahala

• Impact of Operator Variability on the Reproducibility of Tape Stripping Results

  Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra

• Advanced Techniques for Characterizing the Form & Function of Topical Dermatological Drug Products

  Roberts, Michael

• Mathematical Modeling of Skin Absorption and Transport

  Roberts, Michael

• Looking, Feeling and Modelling from the Outside In

  Roberts, Michael

• Topical Products: When Does a Difference Matter?

  Roberts, Michael

• Topical Management of Inflammation & Pain with Diclofenac

  Roberts, Michael