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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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
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Formulation composition, manufacturing process, and characterization of poly(lactide-co-glycolide) microparticles
Park, Kinam; Otte, Andrew; Sharifi, Farrokh; Garner, John; Skidmore, Sarah; Park, Haesun; Jhon, Young Kuk; Kuk; Qin, Bin; Wang, Yan
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Effect of Manufacturing Variables and Raw Materials on the Composition-Equivalent PLGA Microspheres for 1-Month Controlled Release of Leuprolide
Zhou, Jia; Walker, Jennifer; Ackermann, Rose; Olsen, Karl; Hong, Justin; Wang, Yan; Schwendeman, Steven
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Recent Advances in Testing of Microsphere Drug Delivery Systems
Burgess, Diane