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.
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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
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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