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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Physiologically-based Absorption Modeling and Simulation used in Assessing Bioequivalence for Ophthalmic Products
Babiskin, Andrew
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Novel Model-Integrated Designs for Bioequivalence Studies of LAI Products: A Complete Framework with the MonolixSuite
Ayral, Geraldine
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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
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Formulation Drug Product Quality Attributes Additions in Dermal PBPK Model
Babiskin, Andrew
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Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 2
Arora, Sumit
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Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges
Andre, Kris
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Research Overview and Regulatory Experience on Mechanistic Modeling for Generic Dermatological Drug Products
Alam, Khondoker