GDUFA Research Outcomes
LAI Products
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In Vitro-in Vivo Correlation of Parenteral Risperidone Polymeric Microspheres
Shen, Jie; Choi, Stephanie; Qu, Wen; Wang, Yan; Burgess, Diane
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Method Matters: Development of characterization techniques for branched and glucose-poly(lactide-co-glycolide) polymers
Hadar, Justin; Skidmore, Sarah; Garner, John; Park, Haesun; Park, Kinam; Wang, Yan; Qin, Bin; Jiang, Xiaohui; Kozak, Darby
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Drug Release Testing of Long-Acting Intrauterine Systems
Bao, Quanying; Zou, Yuan; Wang, Yan; Kozak, Darby; Choi, Stephanie; Burgess, Diane
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Effect of Implant Formation on Drug Release Kinetics of In Situ Forming Implants
Suh, Min Sung; Kastellorizios, Michail; Tipnis, Namita; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Evaluating and Reporting the Immunogenicity Impacts for Biological Products–a Clinical Pharmacology Perspective
Wang, Yowming; Wang, Jie; Hon, Yuenyi; Zhou, Lin; Fang, Lanyan; Ahn, Hae Young
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Assessing Microstructural Critical Quality Attributes in PLGA Microspheres by FIB-SEM Analytics
Clark, Andrew; Wang, Ruifeng; Qin, Yuri; Wang, Yan; Zhu, Aiden; Lomeo, Joshua; Bao, Quanying; Burgess, Diane; Chen, Jacie; Qin, Bin; Zou, Yuan; Zhang, Shawn
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Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products: Summary of Workshop
Gong, Yuqing; Zhang, Peijue; Yoon, Miyoung; Zhu, Hao; Kohojkar, Ameya; Hooker, Andrew; Ducharme, Murray; Gobburu, Jogarao; Celliere, Geraldine; Gajjar, Parmesh; Li, Bing; Velagapudi, Raja; Tsang, Yu Chung; Schwendeman, Anna; Poli, James; Fang, Lanyan; Lionberger, Robert; Zhao, Liang
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Generating Model-integrated Evidence for Developing and Approving Complex Generic LAI Products
Zhao, Liang
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Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals
Zhao, Liang
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Generating Model-integrated Evidence for Developing & Approving Complex Generic LAI Products.
Zhao, L