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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Translating Scientific Advances to Regulatory Methods Assessment of Cutaneous Pharmacokinetics
Ghosh, Priyanka
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Identification of Research Needs During Product Development Prior to ANDA Submission
Ghosh, Priyanka
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In Silico QbD for Dermal Topical Formulations via TCAT Model Simulations
Spires, Jessica
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Towards Building a Dermal Model for BE Assessment: The Role of Drug Product Characterization and Performance Data
Ghosh, Priyanka
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Advanced Technologies and Evolving Paradigms: Characterization of Topical Semisolid Dosage Forms
Ghosh, Priyanka
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Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 1
Alam, Khondoker
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Mechanistic Modeling and Simulation Approaches for Performance Prediction of Locally Acting Complex Drug Products
Tsakalozou, Eleftheria
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Physiologically-Based Pharmacokinetic Modeling to support Bioequivalence and Drug Approval
Tsakalozou, Eleftheria
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Dermal PBPK Modeling for a Transdermal Delivery System to Assess the Impact of the Application Site on In Vivo Performance
Tsakalozou, Eleftheria
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Leveraging Dermal Physiologically-based Pharmacokinetic Modeling and Simulation Approaches for the Approval of a Generic Diclofenac Sodium Topical Gel
Tsakalozou, Eleftheria