GDUFA Research Outcomes

Complex Oral Products

• All(54)
• Posters(13)
• Presentations(33)
• Papers(8)

• FEV1 Based Bioequivalence Study for Inhaled Corticosteroids

  Zhao, Liang

• Use of Modeling and Simulation to Support New BE Approaches

  Zhao, Liang

• Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

  Tampal, Nilufer

• 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

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

• Considerations and Expectations for in Vitro Release Testing of Complex Formulations

  Wang, Yan

• Development of Generic Long Acting Injectables: Regulatory Challenges and Considerations

  Wang, Yan

• Characterization of Complex Excipients and Formulations

  Wang, Yan