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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Symposium 14: Applying Pharmacometrics to Precision Dosing in the Lifecycle of Long-acting Injectable Products: Drug Development, Regulatory Approval & Clinical Practice
Fang, Lanyan
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Advanced Techniques for Measuring Cutaneous Pharmacokinetics Using Pharmacokinetic Tomography
Evans, Conor
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In Vitro Bioequivalence Data for a Topical Product:Bioequivalence Review Perspective
Dandamudi, Suman
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Evidence from In Vivo Skin Stripping Studies: Utility for Evaluating Topical Bioavailability
Bunge, Annette; Guy, Richard
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Improved Stratum Corneum Sampling In vivo Delivers Obvious Value for Topical Bioequivalence Assessment
Bunge, A
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Correlation of Physicochemical Characteristics and in Vitro Permeation Test (IVPT) Results for Acyclovir Topical Products
Zhao, Liang
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Modeling Derma Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model
Zhao, Liang
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Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model
Zhao, Liang
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Integrating Topical Drug Product Quality Attributes Within Physiologically-based Pharmacokinetic Models
Zhao, Liang
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Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model
Zhao, Liang