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.

• All(202)
• Posters(97)
• Presentations(51)
• Papers(54)

• 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

• 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

• 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

• Manufacture and Process Control of Dexamethasone Intravitreal Implants Produced by Hot Melt Extrusion

  Costello, Mark; Zhang, Feng; Liu, Joseph; Wang, Yan; Qin, Bin

• 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

• 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

• 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

• PLGA-Peptide Interactions Relevant for Octreotide-Loaded PLGA Microspheres

  Beig, Avital; Hong, Justin; Feng, Linglin; Chang, Rae Sung; Zhou, Jia; Ackermann, Rose; Schwendeman, Steven

• Impact of Particle Size on In Vitro Release from Long-Acting Injectable Suspensions

  Bao, Q; Zou, Y; Wang, Y; Choi, S; Burgess, D

• Source Variation of Outer Membranes on Drug Release from Intrauterine Systems

  Bao, Quanying; Zou, Yuan; Wang, Yan; Choi, Stephanie; Kozak, Darby; Burgess, Diane