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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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