GDUFA Research Outcomes
Transdermal Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the transdermal route, including transdermal delivery systems.
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FDA Regulatory Initiatives Related to Generic Dermatological and Transdermal Drug Products
Raney, Sam
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Novel Approaches for Evaluating Bioavailability and Bioequivalence (BE) of Topical Drug Products
Ramezanli, Tannaz
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In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches
Ramezanli, Tannaz
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Best Practices & Efficient Strategies for Generic Topical Product Development
Ramezanli, Tannaz
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How to Structure Efficient Development Programs for Generic Topical Drug Products
Ramezanli, Tannaz
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Product Development Considerations for Transdermal/Topical Delivery Systems
Ramezanli, Tannaz
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An FDA Perspective on the Comparative Analyses of Critical Material, Quality, and Design Attributes for Topical, Transdermal, Rectal, and Vaginal Drug-Device Combination Products
Kelchen, Megan
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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