GDUFA Research Outcomes
MR Oral Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to modified release generic drug products.
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In Vivo Relevance of Dissolution
Jiang, Wenlei
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Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment
Jiang, Wenlei
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Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach
Hu, Meng
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Development of PBPK Model for Predicting Food Impact on BE Assessment
Shoyaib, Abdullah
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Generic Oral Modified Release Drug Products: Establishing Bioequivalence for Additional Strengths
Sun, Wei Jhe; Wang, Rong
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Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation
Fan, Jianghong
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PBPK Absorption Modeling to Support Risk Assessment and Biowaiver for Generic Oral Products
Wu, Fang
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Establishing Bioequivalence for “Additional Strengths” of Oral Modified-Release Drug Products
Boyce, Heather