GDUFA Research Outcomes

Vaginal Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the vaginal route, including vaginal gels and creams.

• All(19)
• Posters(3)
• Presentations(14)
• Papers(2)

• Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

  Donnelly, Mark; Tsakalozou, Eleftheria; Sharan, Satish; Straubinger, Thomas; Bies, Robert; Zhao, Liang

• Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals

  Zhao, Liang

• From Bench to Approval: the Role of GDUFA Research in Promoting Complex Generics

  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

• Long Acting Injectable and Implantable Drug Product Development Regulatory Challenges and Considerations_GSK-CRS Conference

  Wang, Yan

• Challenges Associated with Development of Generic PLGAPLA Based Drug Products

  Wang, Yan

• Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing

  Manna, Soumyarwit