GDUFA Research Outcomes
LAI Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to long-acting injectable, insertable or implantable (collectively, LAI) generic products.
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Microencapsulation of Luteinizing Hormone-Releasing Hormone Agonist in Poly (Lactic-co-Glycolic Acid) Microspheres by Spray Drying
Shi, Nianqiu; Zhou, Jia; Walker, Jennifer; Li, Li; Hong, Justin; Olsen, Karl; Tang, Jie; Ackermann, Rose; Wang, Yan; Qin, Bin; Schwendeman, Anna; Schwendeman, Steven
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Influencing Factors on Gelatin Matrix for Chlorhexidine Delivery
Murawsky, Michael; Kelm, Gary; Kozak, Darby; Qin, Bin; Zou, Yuan; Li, Kevin
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Accelerated In Vitro Release Testing Method for Naltrexone Loaded PLGA Microspheres
Andhariya, Janki; Choi, Stephanie; Wang, Yan; Zou, Yuan; Burgess, Diane; Shen, Jie
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In Vitro Release Testing Method Development for Long-Acting Injectable Suspensions
Bao, Quanying; Wang, Xiaoyi; Zou, Yuan; Wang, Yan; Burgess, Diane J
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Mechanisms of In Vivo Release of Triamcinolone Acetonide from PLGA Microspheres
Doty, Amy; Weinstein, David; Hirota, Keiji; Olsen, Karl; Ackermann, Rose; Wang, Yan; Choi, Stephanie; Schwendeman, Steven
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Effect of Polymer Source on In Vitro Drug Release from PLGA Microspheres
Wan, Bo; Andhariya, Janki; Bao, Quanying; Wang, Yan; Zou, Yuan; Burgess, Diane
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Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System
Sharan, Satish; Choi, Sungwoo; Zou, Yuan; Wang, Yan; Kim, Myong Jin; Fang, Lanyan (Lucy); Choi, Stephanie; Makhlouf, Fairouz; Grosser, Stella C; Zhang, Xinyuan; Zhao, Liang
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Development of In Vitro-In Vivo Correlations for Long-Acting Injectable Suspensions
Bao, Quanying; Wang, Xiaoyi; Wan, Bo; Zou, Yuan; Wang, Yan; Burgess, Daine J
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Impact of Formulation Parameters on In Vitro Release from Long-Acting Injectable Suspensions
Bao, Quanying; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Simultaneous quantification of dexamethasone and 6ß-hydroxydexamethasone in rabbit plasma, aqueous and vitreous humor, and retina by UHPLC-MS/MS
Gu, Jianghong; Wang, Jiang; Krishna, Ashok; Xu, Lin; Stewart, Sharron; Wang, Yan; Faustino, Patrick; Shakleya, Diaa