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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Assay of Clinical Product Long-Term Delivery Systems for PLGA Properties
Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Choi, Stephanie; Wang, Yan
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Role of Excipients on Drug Release from Long-Acting Intrauterine Systems
Fanse, Suraj; Bao, Quanying; Zou, Yuan; Wang, Yan; Burgess, Diane J
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Impact of Polymer Crosslinking on the Properties and Performance of Levonorgestrel Intrauterine Systems
Fanse, Suraj; Bao, Quanying; Zou, Yuan; Wang, Yan; Burgess, Diane
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Effect of Polymer Crosslinking on Release Mechanisms from Long-acting Intrauterine Systems
Fanse, Suraj; Bao, Quanying; Zou, Yuan; Wang, Yan; Burges, Diane J
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Influence of Polymer Crosslinking on the Mechanical Properties of Polydimethylsiloxane Based Intrauterine Systems
Fanse, Suraj; Bao, Quanying; Zou, Yuan; Wang, Yan; Burgess, Diane
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A Cage Implant System For Assessing In Vivo Controlled Release Performance Long-Acting Release Plga Depots
Doty, Amy; Hirota, Keiji; Olsen, Karl; Ackermann, Rose; Feng, Rose; Qu, Wen; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven
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A Cage Implant System for Assessing in Vivo Controlled Release Performance of Long-acting Release PLGA Microspheres
Doty, Amy; Hirota, Keiji; Olsen, Karl; Ackermann, Rose; Feng, Rose; Qu, Wen; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven
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Cage Implants System To Evaluate Mechanisms Of In Vivo Plga Microsphere Release For Ivivc Model Development
Doty, Amy; Hirota, Keiji; Ackermann, Rose; Olsen, Karl; Wang, Yan; Choi, Stephanie; Qu, Wen; Lionberger, Robert; Feng, Meihua; Schwendeman, Anna; Schwendeman, Steven
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Cage Implants System To Evaluate Mechanisms Of In Vivo Plga Microsphere Drug Relase For Ivivc Model Replacement
Doty, Amy; Wang, Yan; Choi, Stephanie; Qu, Wen; Lionberger, Robert; Feng, Meihua; Schwendeman, Anna; Schwendeman, Steven
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Manufacture and Process Control of Dexamethasone Intravitreal Implants Produced by Hot Melt Extrusion
Costello, Mark; Zhang, Feng; Liu, Joseph; Wang, Yan; Qin, Bin