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)

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby

• Development of Model-Informed Bioequivalence Evaluation Strategies for Long-Acting Injectable Products (LAI)

  Karlsson, Matt; Chen, Xiaomei; Hooker, Andrew

• An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• Bioequivalence Assessment for Long-Acting Injectables (LAIs) – FDA Regulatory Perspectives

  Jiang, Wenlei

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

• Model-informed Drug Development for Long-acting Injectable Products

  Fang, Lanyan (Lucy)

• Drug Particle Characterization Inside Long-Acting Intrauterine Systems with 3D Imaging Analytics

  Qin, Yuri; Bao, Quanying; Wang, Yan; Zhu, Aiden; Burgess, Diane; Zhou, Liping; Shawn, Zhang

• Micro-imaging and Microanalysis of PLGA Complex Drug Products by Scanning Electron Microscopy (SEM)

  Liang, Jing; Wang, Yan; Qin, Bin; Zhou, Jia; Schwendeman, Steven; Zheng, Jiwen

• Developing Efficient Bioequivalence Approaches for Generic Vaginal Drug Products

  Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam G.