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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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
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Assessing In Situ Forming Implants Using Real-Time Imaging
Lin, Xinhao; Beringhs, Andre; Hargrove, Derek; Jay, Michael; Wang, Yan; Bin, Qin; Lu, Xiuling
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Assessing Long-Acting Injectable Formulations Using In Vivo Imaging
Lin, Xinhao; Beringhs, Andre; Hargrove, Derek; Jay, Michael; Wang, Yan; Qin, Bin; Lu, Xiuling
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Micro-imaging and Microanalysis of PLGA Complex Drug Products by Scanning Electron Microscopy (SEM)
Liang, Jing; Wang, Yan; Qin, Bin; Zhou, Jia; Schwendeman, Steven; Zheng, Jiwen
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Bioequivalence Testing of Complex Periodontal Products: Drug Release, Matrix Degradation, and Pharmacodynamics in a Canine Periodontal Disease Model
Kozak, Darby; Wang, Yan; Choi, Stephanie; Park, Misook; De Lannoy, Ines; Ines; Brooks, Melissa; Araujo, Joseph
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The Effect of PLGA Molecular Weight on Drug Release from Microspheres
Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane