GDUFA Research Outcomes

LAI Products

• All(273)
• Posters(125)
• Presentations(72)
• Papers(76)

• Generic Long-acting Injectable Product Availability and Approval Standards

  Anno, Krista Anim; Zhang, Lei; Jiang, Wenlei

• Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants

  Costello, Mark; Liu, Joseph; Kuehster, Louise; Wang, Yan; Qin, Bin; Xu, Xiaoming; Li, Qi; Smith, William C; Lynd, Nathaniel A; Zhang, Feng

• Analysis of Copolymerization with Simultaneous Reversibility and Transesterification by Stochastic Model Regression

  Kuehster, Louise; Dai, Jingyi; Thompson, Avery; Jhon, Young Kuk; Wang, Yan; Bin, Qin; Smith, William; Xu, Xiaoming; Zhang, Feng; Lynd, Nathaniel

• A New Analytical Method for Quantifying Acid-End-Cap PLGA inSub-Milligram Quantities

  Garner, John; Skidmore, Sarah; Overdorf, Gary; Hadar, Justin; Park, Haesun; Park, Kinam; Wang, Yan; Jhon, Young Kuk; Smith, William C; Zhang, Deyi; Zou, Yuan

• Manufacturing Dexamethasone Intravitreal Implants: Process Control and Critical Quality Attributes

  Costello, Mark A; Liu, Joseph; Wang, Yan; Qin, Bin; Xu, Xiamoning; Li, Qi; Smith, William C; Lynd, Nathaniel A; Zhang, Feng

• Effect of Material Properties and Extrusion Process Parameters on Permeability of Etonogestrel in Ethylene Vinyl Acetate Films

  Zhong, Ziyue; Ren, Angela; Arbilo, Lance; Zhang, Qiangnan; Smith, William; Qin, Bin; Wang, Yan; Zhang, Feng

• Implant Dynamics, Inner Structure, and their Impact on Drug Release of In Situ Forming Implants Uncovered through CT Imaging

  Lin, Xinhao; Al Zouabi, Nour; Ward, Lauren Elizabeth; Zhen, Zixuan; Darji, Mittal; Masese, Francis; Hargrove, Derek; O’Reilly Beringhs, Andre; Kasi, Rajeswari M; Li, Qi; Zhang, Qiangnan; Qin, Bin; Wang, Yan; Jay, Michael; Yuan, Hong; Lu, Xiuling

• Impact of Manufacturing Variables on Product Performance of Contraceptive Levonorgestrel Intrauterine Systems

  Fanse, S; Bao, Quanying; Zou, Y; Wang, Y; Burgess, D J

• Towards in vitro – In vivo correlation models for in situ forming drug implants

  Wang, Xiaoyi; Roy, Mckenzie; Wang, Ruifeng; Kwok, Owen; Wang, Yinhang; Wang, Yan; Qin, Bin; Burgess, Daine J

• Hot-Melt Extrusion-Based Dexamethasone-PLGA Implants: Physicochemical, Physicomechanical, and Surface Morphological Properties and In Vitro Release Corrected for Drug Degradation

  Ghaffari, AA; Matter, BA; Hartman, RR; Bourne, DWA; Wang, Y; Choi, S; Kompella, UB