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.
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Advanced Analytical Methods in Generic Drug Development and Approval
Kozak, Darby
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Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods
Kozak, Darby
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Bioequivalence of Transdermal Systems
Luke, Markham
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Generic Drugs and Their Role in Bringing Next Generation Products: An FDA Perspective
Luke, Markham
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Generic Drugs for Dermatology
Luke, Markham
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Implications of Skin Anatomy, Skin (Patho-)Physiology, and Product Physico-Chemistry on FDA Regulatory Apprach for Generic Dermatologic Products
Luke, Markham
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Drug Compounding and the Dermatologist
Luke, Markham
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Developing Successful Topical Therapies for Dermatologic Disease
Luke, Markham
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Overcoming Barriers and Improving Patient Access to Topical Dermatological Drugs
Luke, Markham
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Novel Methodologies to Assess Cutaneous Bioavailability and Bioequivalence: Dermal Microdialysis and Coherent Raman Imaging
Kuzma, Benjamin