GDUFA Research Outcomes
PBPK Models
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.
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Considerations and Potential Regulatory Applications for a Model Master File
Tsakalozou, Eleftheria
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Applications of Mechanistic Modeling and Simulation Tools on the Performance of Locally Acting Complex Drug Products
Tsakalozou, Eleftheria
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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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Leveraging Dermal Physiologically-based Pharmacokinetic Modeling and Simulation Approaches for the Approval of a Generic Diclofenac Sodium Topical Gel
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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Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 1
Alam, Khondoker
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Scientific and Regulatory Considerations on Dermal PBPK Modeling for Virtual Bioequivalence Assessments and Decision-making
Tsakalozou, Eleftheria
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Physiologically-based Pharmacokinetic Modeling and Simulation Approaches: Best Practices for Regulatory Applications Related to Locally-acting Generic Drugs
Tsakalozou, Eleftheria
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Physiologically-based Pharmacokinetic Modeling to Guide Study Design and Product Development for Generic Dermatological Products
Tsakalozou, Eleftheria