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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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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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 to Guide Study Design and Product Development for Generic Dermatological Products
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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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 for the Development of Dermatological Drug Products and its Regulatory Impact
Tsakalozou, Eleftheria
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Physiologically-based pharmacokinetic modeling and simulation used in assessing bioequivalence for generic dermatological products
Tsakalozou, Eleftheria
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Continuous Skin Sampling Methods for the Assessment of Cutaneous PK-Based Bioequivalence
Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank
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Integration of Biopredictive Dissolution and PBPK Models for Evaluation of GI Locally Acting Products: PART I
Thomas, Sherin
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IVRT Studies During Topical Product Development: Challenges in Method Development and Transfer
Thakker, Kailas