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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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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Impact of Excipients on Drug Permeation to Support Biowaivers for Non-Q1/Q2 Products
Bode, Chris
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Intestinal Influx Transporters: A Missing Piece in the Puzzle?
Zhang, Lei
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Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations
Wang, Yan
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Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modeling
Tan, Ming-Liang
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Establishing Bioequivalence for Generic Oral Modified-Release Products: Regulatory Considerations and Utility of In Vivo Predictive Dissolution
Lee,Sue-Chih
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Modeling for Success: A Case Example for Oseltamivir Phosphate
Mousa, Youssef
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Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices
Jiang, Wenlei