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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Using R for Generic Drug Evaluation and SABE R-package for Assessing Bioequivanlence of Topical Dermatological Products
Rantou, Elena
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Statistical Issues with Aberrant IVRT/IVPT Data- FDA Perspective
Rantou, Elena
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Assessing Bioequivalence of Locally-Acting Generic Products; Statistical Controversies and Arising Issues
Rantou, Elena
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Special Cases for the Statistical Evaluation of Bioequivalence: An Example of in-Vitro, Skin Permeation Test Data
Rantou, Elena
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GDUFA Science and Research Program
Raney, Sameersingh
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A Regulatory Perspective on Physicochemical, Structural, and Performance Characterization of Topical Semisolid Products
Raney, Sameersingh
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Physicochemical, Structural, and Performance Characterization of Topical Semisolid Products
Raney, Sam
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In Vitro Release Test (IVRT) Fundamentals: Scientific and Practical Considerations
Raney, Sam
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Overview of Breakout Session on Topical Drug Products: Workshop on Complex Generic Drug Products (CGDPs)
Raney, Sam
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When Do Formulation Differences in Topical Dosage Forms Impact Their Function: Emerging Insights and Implications for Bioequivalence Approaches
Raney, Sam