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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The Impact of In vitro Test Methods on Drug Release from PLGA Microparticles
Skidmore, Sarah; Garner, John; Park, Kinam; Park, Haesun; Choi, Stephanie; Wang, Yan
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PLGA Microsphere Stability Characterization Using Image-Based Key Performance Attributes and Release Prediction
Shen, Mike; Wang, Yan; Zhang, Shawn; Qin, Bin; Wang, Ruifeng; Bao, Quanying; Burgess, Diane
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Effect Of Manufacturing Process Parameters On In Vitro Performance Of Peptide Microspheres.
Shen, Jie; Qu, Wen; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Effect of Manufacturing Process Parameters on Physicochemical Properties of Peptide Microspheres
Shen, Jie; Qu, Wen; Wang, Yan; Choi, Stephanie; Burgess, Diane
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In Vitro-In Vivo Correlation Of Risperidone Microspheres
Shen, Jie; Tipnis, Namita; Choi, Stephanie; Qu, Wen; Wang, Yan; Burgess, Diane
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Development of an In Vitro Release Testing Method for Porous PLGA Microsphere
Shen, Jie; Qu, Wen; Choi, Stephanie; Wang, Yan; Burgess, Diane
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Development of In Vitro-In Vivo Correlation for Long Acting Injectible Microsphere Formulations
Shahraz, Azar; Mullin, James; Lukacova, Viera; Bolger, Michael; Woltosz, Walt
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Effect of Solvent Isomeric Structures on the Dissolution of PLGAs with Different Lactide:Glycolide (L:G) Ratios
Qin, Bin; Garner, John; Hadar, Justin; Skidmore, Sarah; Jessmon, F; Park, Haesun; Park, Kinam; Wang, Yan; Jhon, Young Kuk
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Drug Particle Characterization Inside Long-Acting Intrauterine Systems with 3D Imaging Analytics
Qin, Yuri; Bao, Quanying; Wang, Yan; Zhu, Aiden; Burgess, Diane; Zhou, Liping; Shawn, Zhang
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Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space
Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu