GDUFA Research Outcomes
OA Models
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.
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PBPK Absorption Modeling to Support Risk Assessment and Biowaiver for Generic Oral Products
Wu, Fang
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Model-Integrated BE Approaches for Long-Acting Injectables
Ducharme, Murray
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Model Integrated Equivalence for BE Assessment of Long Acting Injectables: In Silico Continuation to Steady State
Ducharme, Murray
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Development Strategies for Generic Topical Products with Formulation Differences to Reference Listed Drug
Dubey, Vaibhav
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PBPK Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products
Wu, Fang
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Integrating Biopharmaceutic Data and Gastrointestinal Physiology Using Mechanistic Modeling
Cristofoletti, Rodrigo
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ASME V&V 40 for Establishing Credibility of CFD Models
Craven, Brent
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Opening Remarks to the FDA and the Center for Research on Complex Generics (CRCG) Workshop: Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches
Corrigan-Curay, Jacqueline
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Utilizing Mechanistic Dermal Absorption Models to Assess Virtual BE
Clarke, James
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A Population PK Based Model-Integrated BE Platform
Chen, X; Nyberg, H; Assawasuwannakit, P; Ryeznik, Y; Karlsson, M