GDUFA Research Outcomes
LAI Products
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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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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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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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The Effect of Crosslinking Reagent Ratio of a 5-Year Contraceptive Implant on Drug Release
Price, Claire; Shen, Jie; Zou, Yuan; Wang, Yan; Kozak, Darby; Choi, Stephanie; Burgess, Diane
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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
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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
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Population Pharmacokinetic/Pharmacodynamic (PKPD) Modeling for Long Acting Injectable(LAI) Products and Statistical Analysis for Bioequivalence(BE) Assessment
Paul, Prokash; Yoon, Seongkyu; Kim, Namjoon; Trunfio, Nicholas; Handelman, Garry; Kim, Jaeyeon