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(24)
• Posters(5)
• Presentations(16)
• Papers(3)

• Development of Graphical Interface in R Shiny for PBPK Model-based Prediction and Simulation of Drug Delivery in the Female Reproductive Tract

  Straubinger, Thomas; Li, Xinnong; Valicherla, Guru R; Zhang, Zhongfang; Achilles, Sharon L; Donnelly, Mark; Zhao, Liang; Tsakalozou, Eleftheria; Chen, Beatrice A; Rohan, Lisa C; Bies, Robert

• 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.