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 and Characterization of Composition-Equivalent Formulations to the One-Month Lupron Depot
Zhou, Jia; Walker, Jennifer; Ackermann, Rose; Olsen, Karl; Hong, Justin; Wang, Yan; Jiang, Xiaohui; Schwendeman, Anna; Schwendeman, Steven
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Reverse Engineering of the one-month Lupron Depot and Development of Q1/Q2 Formulations
Zhou, Jia; Hirota, Keiji; Ackermann, Rose; Walker, Jennifer; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven
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Reverse Engineering of the one-month Lupron Depot and Development of Q1/Q2 Formulations
Zhou, Jia; Hirota, Keiji; Ackermann, Rose; Walker, Jennifer; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven
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Scientific Gap Analysis of Polymeric In Situ Forming Depot Products for the Development of GDUFA Research Projects
Zhang, Qiangnan; Qin, Bin; Wang, Yan; Li, Qi; Kozak, Darby
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Understanding the Drug Release Mechanism of Long-term Intrauterine Systems
Zaman, Rokon; Smith, William; Park, Jin; Liang, Jing; Feng, Xin; Fan, Zhaobo; Wang, Yan; Zheng, Jiwen; Xu, Xiaoming
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Effect of Coacervation Processing Parameters on In vitro Drug Release from Minocycline Hydrochloride Microspheres
Wang, Ruifeng; Bao, Quanying; Clark, Andrew G; Wang, Yan; Qin, Bin; Zhang, Shawn; Burgess, Diane J
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Effect of Coacervation Processing Parameters on Drug Release from Minocycline Hydrochloride Microspheres
Wang, Ruifeng; Bao, Quanying; Wang, Yan; Qin, Bin; Lomeo, Josh; Zhang, Shawn; Burgess, Diane
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Formulation Optimization of PLGA Microspheres Prepared Using a Coacervation Method
Wang, Ruifeng; Bao, Quanying; Wang, Yan; Choi, Stephanie; Zhou, Liping; Zhang, Shawn; Burgess, Diane
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Impact of Polymer Source Variation on Risperidone Microsphere Performance
Wan, Bo; Andhariya, Janki; Bao, Quanying; Wang, Yan; Zou, Yuan; Burgess, Diane
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Effect of Polymer Source Variation on Physicochemical Properties of Risperidone Microspheres
Wan, Bo; Andhariya, Janki; Bao, Quanying; Wang, Yan; Choi, Stephanie; Zou, Yuan; Burgess, Diane