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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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
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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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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
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Design, Fabrication, And Evaluation Of A Small Volume Biorelevant Dissolution Apparatus For Extended-release Periodontal Microparticles
Patel, Sravankumar; Greene, Ashlee; Macpherson, John; Basha, Imad; Desai, Stuti; Zou, Yuan; Sfeir, Charles; Rothstein, Sam; Little, Steven; Rohan, Lisa
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Application Of USP 4 Dissolution Apparatus To Assess Dissolution Of Microparticles For Periodontal Disease.
Patel, Sravankumar; Greene, Ashlee; Rothstein, Sam; Zou, Yuan; Choi, Stephanie; Glowacki, Andrew; Gottardi, Riccardo; Sfeir, Charles; Little, Steven; Rohan, Lisa