GDUFA Research Outcomes
IR Oral Products
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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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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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Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices
Jiang, Wenlei
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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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Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation
Fan, Jianghong
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A Literature Review on the Performance of Tiny Tract for In Vitro Modeling (tiny-TIM) to Predict Food-Drug and pH-Dependent Drug-Drug Interaction Risks
Chang, Yuhua; Zhao, Gang; Nguyen, Duyen; Zhang, Qi; Lim, Hye-Lim
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Utilizing PBPK Absorption Modeling to Evaluate Impact of Single-Sex on Bioequivalence Evaluation of Atorvastatin Immediate Release Tablets
Cheng, Yi Hsien; Wu, Fang; Zhao, Liang; Fang, Lanyan (Lucy)