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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Using Physiologically-Based Pharmacokinetic Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver
Wu, Fang
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Application of PBPK Modeling in Regulatory Submission: FDA Experience on Generic Drugs
Wu, Fang
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Role of GDUFA Research on Resolving Technical and Regulatory Challenges for Complex Generic Drug Development and Approval
Wang, Yan
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Considerations for the Qualitative Sameness Evaluation of a Proposed Generic Formulation
Wang, Yan
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Mechanistic Modeling to Support Development and Approval of Non-Orally Administered Generic Drug Products
Walenga, Ross
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In Silico Modeling to Support Development and Approval of Generic Orally Inhaled Drug Products in the United States
Walenga, Ross
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Leveraging Modeling Approaches to Support Bioequivalence Determination for Generic Orally Inhaled Drug Products in the United States
Walenga, Ross
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Orally Inhaled Drug Product PSGs: Considerations for Using Modeling and Simulation with Alternative BE Approaches
Walenga, Ross
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Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate
Walenga, Ross; Tsakalozou, Eleftheria; Chopski, Steven; Fang, Lanyan (Lucy); Liang, Zhao
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FDA Recommendations for Alternative Bioequivalence Approaches: Design, Validation, and Use Case for In Silico Studies
Walenga, Ross