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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Developing Regulatory Standards for Characterizing Critical Quality Attributes and Performance Attributes for Topical Semisolid Dosage Forms
Raney, Sam
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Novel Approaches for Evaluating Bioavailability and Bioequivalence (BE) of Topical Drug Products
Ramezanli, Tannaz
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IVRT Method Development, Validation, and Transfer Theoretical Principles and Practical Challenges
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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Bioquivalence of Topical Products Scientific Consideration
Ramezanli, Tannaz
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CGDP with a Locally-Acting Route of Delivery Including Topical Dermatological Drug Products
Ramezanli, Tannaz
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PBPK Modeling of Transdermal Selegiline Disposition Discrepancy in Special Populations
Puttrevu, Santosh Kumar
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Demonstrating Dermatological Bioequivalence Beyond the in vivo Clinical Endpoint Bioequivalence Study
Peters, John