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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Evaluation of Level A In Vitro In Vivo Correlations (IVIVC) for Nicotine and Fentanyl Transdermal Delivery Systems (TDS) with Transient Heat Exposure by Using Multiple Approaches
Shin, Soo Hyeon
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In Vitro and In Vivo Evaluation of Three Fentanyl Transdermal Delivery Systems In Conjunction With Transient Heat Exposure
Shin, Soo Hyeon
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Statistical Issues with Aberrant IVRT/IVPT Data- FDA Perspective
Rantou, Elena
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Overview of the Topical and Transdermal Stimuli Article “Advances in Product Quality and Performance Tests for Topical and Transdermal Products – View of the USP Expert Panel” – Feedback to USP and Next Steps
Raney, Sam
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Physicochemical, Structural, and Performance Characterization of Topical Semisolid Products
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
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Advances in Topical Bioequivalence Assessments: Characterization-Based Approaches
Raney, Sam
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A Generic Drugs Perspective on the Use of In Vitro Assesment Methods
Raney, Sam
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Research Activities, Scientific Advances, & Modernization of Bioequivalence Standards for Generic Topical and Transdermal Products
Raney, Sam