GDUFA Research Outcomes
LAI Products
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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
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A Real-Time NMR Method for Measurement of In Vitro Aggregation Kinetics of Degarelix Drug Products
Patil, Sharadrao; Qin, Bin; Wang, Yan; Ahmed, Snober; Yilmaz, Huzeyfe; Jiang, Xiaohui; Keire, David; Chen, Kang
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Manufacturing and Characterization of Long-Acting Levonorgestrel Intrauterine Systems
Bao, Quanying; Gu, Bing; Price, Claire; Zou, Yuan; Wang, Yan; Kozak, Darby; Choi, Stephanie; Burgess, Diane
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Effect of Crosslinking on the Physicochemical Properties of Polydimethylsiloxane-Based Levonorgestrel Intrauterine Systems
Fanse, Suraj; Bao, Quanying; Zou, Yuan; Wang, Yan; Burgess, Daine J
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FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes
Wang, Yan; Qin, Bin; Xia, Grace; Choi, Stephanie
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In Vitro-In Vivo Correlation for Complex Non-Oral Drug Products: Where do we Stand?
Burgess, Diane
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A Reproducible Accelerated In Vitro Release Testing Method for PLGA Microspheres
Shen, Jie; Lee, Kyulim; Choi, Stephanie; Qu, Wen; Wang, Yan; Burgess, Diane
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Dissolution Chamber for Small Drug Delivery System in the Periodontal Pocket
Ren, Wei; Murawsky, Michael; La Count, Terri; Wanasathop, Apipa; Hao, Xin; Kelm, Gary; Kozak, Darby; Qin, Bin; Li, Kevin