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 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
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Evaluation of Deficiencies Associated with In-vitro Release Test Submitted in Abbreviated New Drug Applications to Support Bioequivalence of Acyclovir Ointment
Patel, Sravankumar; Greene, Ashlee; Rothstein, Sam; Zou, Yuan; Choi, Stephanie; Glowacki, Andrew; Gottardi, Riccardo; Sfeir, Charles; Little, Steven; Rohan, Lisa
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Simulation of in vitro Dissolution and Degradation of Orntide-loaded PLGA Microspheres
Mullin, James; Van Osdol, William; Lukacova, Viera; Woltosz, Walter; Bolger, Michael
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Development Of An In Vitro Mechanistic Model That Describes Drug Release From Risperidone Long-Acting Injectable Microspheres
Mullin, James; Lukacova, Viera; Woltosz, Walter; Bolger, Michael
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Significance of Cryogenic Broad Ion Beam Milling in Evaluating Microstructures of PLGA-based Drug Products
Ma, Youlong; Liang, Jing; Zheng, Jiwen; Wang, Yan; Ashraf, Muhammad; Srinivasan, Charudharshini
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Assessing In Situ Forming Implant Formulations Using In Vivo Imaging
Lin, Xinhao; O’Reilly Beringhs, Andre; Hargrove, Derek; Jay, Michael; Wang, Yan; Bin, Qin; Lu, Xiuling