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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• Implications of Skin Anatomy, Skin (Patho-)Physiology, and Product Physico-Chemistry on FDA Regulatory Apprach for Generic Dermatologic Products

  Luke, Markham

• Drug Compounding and the Dermatologist

  Luke, Markham

• Overcoming Barriers and Improving Patient Access to Topical Dermatological Drugs

  Luke, Markham

• Developing Successful Topical Therapies for Dermatologic Disease

  Luke, Markham

• Topical Bioequivalence Update

  Lionberger, Robert

• Topical Bioequivalence Update

  Lionberger, Robert

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

  Kuzma, Benjamin

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

  Kuzma, Benjamin

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

  Kuzma, Benjamin

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

  Kuzma, Benjamin