GDUFA Research Outcomes

IR Oral Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to immediate release generic drug products.

• All(29)
• Posters(10)
• Presentations(14)
• Papers(5)

• Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients

  Wang, Yan

• Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations

  Wang, Yan

• Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modeling

  Tan, Ming-Liang

• Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices

  Jiang, Wenlei

• In Vivo Relevance of Dissolution

  Jiang, Wenlei

• Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment

  Jiang, Wenlei

• Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach

  Hu, Meng

• Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation

  Fan, Jianghong

• 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

• 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)