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 Reaction Temperature on PLGA Properties and Semi-Solvent Interactions
Garner, John; Hadar, Justin; Skidmore, Sarah; Jessmon, F; Park, Haesun; Park, Kinam; Jhon, Young Kuk; Qin, Bin; Wang, Yan
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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
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Scanning Analysis of Semi-Solvent Impact (SASSI) Assays of Naltrexone Microparticles Prepared by Different Manufacturing Solvents and Conditions
Garner, John; Hadar, Justin; Skidmore, Sarah; Jessmon, F; Park, Haesun; Park, Kinam; Jhon, Young Kuk; Qin, Bin; Wang, Yan
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Effect of Solvent Molar Volume on Its Ability to Solubilize PLGAs and Potential Implications for Understanding Polymer Structure
Garner, John; Hadar, Justin; Skidmore, Sarah; Jessmon, F; Park, Haesun; Park, Kinam; Jhon, Young Kuk; Qin, Bin; Wang, Yan
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Effect of Solvent Isomeric Structures on the Dissolution of PLGAs with Different Lactide:Glycolide (L:G) Ratios
Garner, J; Hadar, J; Skidmore, S; Jessmon, F; Park, H; Park, K; Wang, Y; Qin, B; Jhon, Y
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Use of Optical-Laser-Scanning (OLS) Microscope to Assay Microparticle Morphological Changes
Garner, J; Hadar, J; Skidmore, S; Jessmon, F; Park, H; Park, K; Wang, Y; Qin, B; Jhon, Y
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Effect of Solvents and Their Isomers on Dissolution of PLGAs with Different Lactide:Glycolide (L:G) Ratios
Garner, John; Hadar, Justin; Skidmore, Sarah; Park, Haesun; Park, Kinam; Qin ,Bin; Jiang, Xiaohui; Wang, Yan
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Separation and Analysis of Poly(lactide-co-glycolide) in Trelstar® 22.5 mg Formulation
Garner, John; Hadar, Justin; Skidmore, Sarah; Park, Haesun; Park, Kinam; Qin ,Bin; Jiang, Xiaohui; Wang, Yan
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Assay of PLGA Types in Microparticle Depo Formulations
Garner, John; Skidmore, Sarah; Hadar, Justin; Park, Kinam; Park, Haesun; Choi, Stephanie; Wang, Yan
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Assay of polymeric sustained systems for carrier properties.
Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Choi, Stephanie; Wang, Yan