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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IVPT Studies with Sunscreen Products: Experimental Parameters
Yang, Yang
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Using PBPK Model to Support Risk Assessment for Oral Products
Wu, Fang
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Assessing Food Impact on Bioequivalence Using Physiologically-Based Pharmacokinetic Modeling
Wu, Fang
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Challenges and Opportunities when Using Oral PBPK to Support Risk Assessment and Biowaiver in Regulatory Submissions
Wu, Fang
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Bioequivalence Evaluation of Pediatric Products Using Physiologically Based Pharmacokinetic Modeling
Wu, Fang
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Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations
Wu, Fang
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Considerations for the Qualitative Sameness Evaluation of a Proposed Generic Formulation
Wang, Yan
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Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients
Wang, Yan
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Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations
Wang, Yan
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ANDA and Pre-ANDA Experience with OIDP Modeling
Walenga, Ross