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(31)
• Posters(10)
• Presentations(14)
• Papers(7)

• Intestinal Influx Transporters: A Missing Piece in the Puzzle?

  Zhang, Lei

• Physiologically Based Pharmacokinetic Modeling for BCS IV Drugs and Case Examples

  Wu, Fang

• 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