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)

• 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

• New developments in the Assessment of Cutaneous Bioavailability and Bioequivalence of Topical Dermatological Drug Products Using Dermal Microdialysis

  Senemar, Sharareh

• Mathematical Modeling of Skin Absorption and Transport

  Roberts, Michael

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

  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

• Topical Semisolid Drug Product Critical Quality Attributes (Q3 Characterization) with Relevance to Topical Bioequivalence

  Roberts, Michael

• Mathematical Modeling of Skin Absorption and Transport: Foundation Lecture

  Roberts, Michael