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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Nifedipine Release From Extended-Release Solid Oral Formulations Using In Vitro Dissolution Testing Under Simulated Gastrointestinal Compression
Gao, Zongming; Tian, Li; Rodriguez, Jason
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Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies
Zhao, Liang
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FEV1 Based Bioequivalence Study for Inhaled Corticosteroids
Zhao, Liang
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Use of Modeling and Simulation to Support New BE Approaches
Zhao, Liang
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Beyond General Guidance: Tailored PSG Recommendations for Immediate Release Drug Products
Zhang, Qi
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Intestinal Influx Transporters: A Missing Piece in the Puzzle?
Zhang, Lei
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Totality of Evidence Including PBPK Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets (Part II)
Wu, Fang
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PBPK Absorption Modeling to Support Risk Assessment and Biowaiver for Generic Oral Products
Wu, Fang
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Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations
Wang, Yan
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PBPK Modeling to Predict Drug-Drug Interactions between Omeprazole and Extended-Release Nifedipine
Tan, Ming-Liang