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)

• Dermal PBPK Modeling for a Transdermal Delivery System to Assess the Impact of the Application Site on In Vivo Performance

  Tsakalozou, Eleftheria

• Leveraging Dermal Physiologically-based Pharmacokinetic Modeling and Simulation Approaches for the Approval of a Generic Diclofenac Sodium Topical Gel

  Tsakalozou, Eleftheria

• Scientific and Regulatory Considerations on Dermal PBPK Modeling for Virtual Bioequivalence Assessments and Decision-making

  Tsakalozou, Eleftheria

• Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 1

  Alam, Khondoker

• Promising Technologies: Continuous Skin Sampling Methods for Cutaneous PK-Based Bioequivalence Assessment

  Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank

• Assessing Topical Drug Bioavailability in the Skin Using Raman Spectroscopy

  Tabosa, Alice

• Scientific Challenges for Generic Transdermal Products: Recent Advances and Future Research

  Stinchcomb, Audra

• Characterizing In Vitro Bioavailability of Acyclovir and Metronidazole Topical Products, and In Vitro-In Vivo Correlation Results with Transdermal Systems

  Stinchcomb, Audra

• Bioavailability And Bioequivalence Of Products Applied To The Skin

  Stinchcomb, Audra

• Evaluating Topical Bioavailability In Vivo by Skin Stripping and In Vitro by IVPT

  Stinchcomb, Audra