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 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

• 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