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)

• Developing Successful Topical Therapies for Dermatologic Disease

  Luke, Markham

• Topical Bioequivalence Update

  Lionberger, Robert

• Topical Bioequivalence Update

  Lionberger, Robert

• Novel Methodologies to Assess Cutaneous Bioavailability and Bioequivalence: Dermal Microdialysis and Coherent Raman Imaging

  Kuzma, Benjamin

• Recent Advancements in Dermal Microdialysis to Assess Topical Bioavailability And Bioequivalence

  Kuzma, Benjamin

• In-Vivo Flux: A Breakthrough in IVIVC of Topical Dermatological Formulations

  Kuzma, Benjamin

• Estimation of in-Vivo Percutaneous Permeation (Flux) and Cumulative Amount Input of Metronidazole Formulations in Mini-Pigs�۪ Dermis

  Kuzma, Benjamin

• Formulation Considerations for In Vitro Characterization Based Approaches of Locally Acting Complex Generic Drug Products

  Kozak, Darby

• Advanced Analytical Methods in Generic Drug Development and Approval

  Kozak, Darby

• Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods

  Kozak, Darby