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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Assessing In Situ Forming Implants Using Real-Time Imaging
Lin, Xinhao; Beringhs, Andre; Hargrove, Derek; Jay, Michael; Wang, Yan; Bin, Qin; Lu, Xiuling
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Assessing Long-Acting Injectable Formulations Using In Vivo Imaging
Lin, Xinhao; Beringhs, Andre; Hargrove, Derek; Jay, Michael; Wang, Yan; Qin, Bin; Lu, Xiuling
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Micro-imaging and Microanalysis of PLGA Complex Drug Products by Scanning Electron Microscopy (SEM)
Liang, Jing; Wang, Yan; Qin, Bin; Zhou, Jia; Schwendeman, Steven; Zheng, Jiwen
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Bioequivalence Testing of Complex Periodontal Products: Drug Release, Matrix Degradation, and Pharmacodynamics in a Canine Periodontal Disease Model
Kozak, Darby; Wang, Yan; Choi, Stephanie; Park, Misook; De Lannoy, Ines; Ines; Brooks, Melissa; Araujo, Joseph
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The Effect of PLGA Molecular Weight on Drug Release from Microspheres
Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane
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Characterizing Release Mechanisms of Leuprolide Acetate-loaded PLGA Microspheres for IVIVC development I: In Vitro Evaluation
Hirota, Keiji; Doty, Amy; Ackermann, Rose; Zhou, Jia; Olsen, Karl; Feng, Meihua; Wang, Yan; Choi, Stephanie; Qu, Wen; Schwendeman, Anna; Schwendeman, Steven
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Reverse engineering of the one-month Lupron Depot
Hirota, Keiji; Zhou, Jia; Ackerman, Rose; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven
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Characterizing Release Mechanisms of Leuprolide-Loaded PLGA Microparticles for IVIVC Development
Hirota, Keiji; Doty, Amy; Ackerman, Rose; Olsen, Karl; Feng, Meihua; Wang, Yan; Choi, Stephanie; Qu, Wen; Schwendeman, Anna; Schwendeman, Steven
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Compositional Analysis of Glucose-poly(lactide-co-glycolide) in Sandostatin®LAR Formulation
Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Qin, Bin; Jiang, Xiaohui; Wang, Yan
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Analysis of the Branch Units of Glucose-poly(lactide-co-glycolide) in Sandostatin® LAR Formulation
Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Qin, Bin; Jiang, Xiaohui; Wang, Yan