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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PLGA Microsphere Formulation Development Guided by Microstructure Equivalence Assessment Using FIB-SEM Imaging and AI Image Analytics
Clark, Andrew; Wang, Ruifeng; Wang, Yan; Qin, Bin; Zhu, Aiden; Bao, Quanying; Lomeo, Josh; Burgess, Diane; Zhang, Shawn
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Investigation of the Thermal Stability and Hydrolytic Degradation Kinetics of Poly(lactide-co-glycolide) Melts
Chen, Beibei; Costello, Mark; Kuehster, Louise; Lynd, Nathaniel; Qin, Bin; Wang, Yan; Zhang, Feng
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Preparation of Long-acting Release Microspheres for Octreotide LAR using Formulation Techniques to Control the Release Kinetics
Beig, Avital; Ackermann, Rose; Jiang, Xiaohui; Wang, Yan; Schwendeman, Steven
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PLGA-Peptide Interactions Relevant for Octreotide-Loaded PLGA Microspheres
Beig, Avital; Hong, Justin; Feng, Linglin; Chang, Rae Sung; Zhou, Jia; Ackermann, Rose; Schwendeman, Steven
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Impact of Particle Size on In Vitro Release from Long-Acting Injectable Suspensions
Bao, Q; Zou, Y; Wang, Y; Choi, S; Burgess, D
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Source Variation of Outer Membranes on Drug Release from Intrauterine Systems
Bao, Quanying; Zou, Yuan; Wang, Yan; Choi, Stephanie; Kozak, Darby; Burgess, Diane
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In Vitro Release Testing Methods for Long-Acting Intrauterine Systems
Bao, Quanying; Zou, Yuan; Wang, Yan; Choi, Stephanie; Kozak, Darby; Burgess, Diane
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Accelerated Drug Release Method for Long-Acting Levonorgestrel Intrauterine Systems
Bao, Quanying; Zou, Yuan; Wang, Yan; Kozak, Darby; Choi, Stephanie; Burgess, Diane
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In Vitro Release Testing of Long-Acting Levonorgestrel Intrauterine System
Bao, Quanying; Gu, Bing; Price, Claire; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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In Vitro Release Testing of Long-Acting Levonorgestrel Intrauterine System
Bao, Quanying; Gu, Bing; Price, Claire; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane