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(19)
• Posters(4)
• Presentations(12)
• Papers(3)

• Development and Validation of a HPLC Method for Dissolution and Stability Assay of Liquid-Filled Cyclosporine Capsule Drug Products

  Xu, Xiaoming; Sayeed, Vilayat; Khan, Mansoor

• Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms

  Lex, Timothy; Rodriguez, Jason; Zhang, Lei; Jiang, Wenlei; Gao, Zongming

• Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

  Zhang, Xinyuan; Duan, John; Kesisoglou, Filippos; Novakovic, Jasmina; Amidon, Gordon; Jamei, Masoud; Lukacova, Viera; Eissing, Thomas; Tsakalozou, Eleftheria; Zhao, Liang; Lionberger, Robert

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang

• FEV1 Based Bioequivalence Study for Inhaled Corticosteroids

  Zhao, Liang

• Use of Modeling and Simulation to Support New BE Approaches

  Zhao, Liang

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

  Zhang, Lei

• 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