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)

• Bioequivalence of Topical Products

  Yu, Lawrence

• The Pursuit of Alternative Methodologies for Demonstrating Bioequivalence for Generic Topical Dermatologic Drug Products

  Wilkin, Jonathan

• Role of GDUFA Research on Resolving Technical and Regulatory Challenges for Complex Generic Drug Development and Approval

  Wang, Yan

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

• In Silico QbD for Dermal Topical Formulations via TCAT Model Simulations

  Spires, Jessica

• Dual Modality Monitoring of Topical Formulations within Human Skin using Stimulated Raman Scattering (SRS) Microscope

  Tu, Dandan; Lemberger, Nick Sidney; Wallmeier, Kristin; Riseman, Jackson; Kuzma, Benjamin A; Wei, Yuxiao; Khoo, Ting Chean; Fallnich, Carsten; Evans, Conor L

• Enhanced Understanding of Structure Performance Relationship Using Modeling and Simulation ��� A Case Study with Dapsone Topical Gel

  Tsakalozou, Eleftheria

• Applications of Mechanistic Modeling and Simulation Tools on the Performance of Locally Acting Complex Drug Products

  Tsakalozou, Eleftheria

• Mechanistic Modeling and Simulation Approaches for Performance Prediction of Locally Acting Complex Drug Products

  Tsakalozou, Eleftheria

• Physiologically-Based Pharmacokinetic Modeling to support Bioequivalence and Drug Approval

  Tsakalozou, Eleftheria