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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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
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Correlation analysis of refractive index (dn/dc) for PLGAs with different ratios of lactide to glycolide,
Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Kozak, Darby; Wang, Yan
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Solvent-dependent PLGA Solubility for Separation of PLGAs with Different L:G Ratios
Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Kozak, Darby; Jiang, Xiaohui; Wang, Yan
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The Effect of Lactide:Glycolide Ratio on PLGA Solubility in Selective Solvents
Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Kinam; Choi, Stephanie; Wang, Yan
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Morphological Analysis of Naltrexone-Poly(lactide-co-glycolide) (NTX-PLGA) Microparticles: Dynamic Role of Naltrexone on PLGA Degradation
Garner, J; Hadar, J; Skidmore, S; Jessmon, F; Park, H; Park, K; Qin, B; Jhon, Y K; Wang, Y
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Scanning Analysis of Semi-Solvent Impact Using Sequential Solvent Vapor (SASSI-SSV): Assay of Poly(lactide-co-glycolide)-Naltrexone (PLGA-NTX) Microparticles
Garner, J; Hadar, J; Skidmore, S; Jessmon, F; Park, H; Park, K; Qin, B; Jhon, Y K; Wang, Y