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(300)
• Posters(133)
• Presentations(76)
• Papers(91)

• 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

• 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

• 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

• 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

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

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

• 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

• Tailoring Drug Release from Long-Acting Contraceptive Levonorgestrel Intrauterine Systems

  Fanse, Suraj; Bao, Quanying; Zou, Y; Wang, Yan; Burgess, D J

• Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables

  Silva, Daniela A; Le Merdy, Maxime; Alam, Khondoker; Wang, Yan; Bao, Quanying; Malavia, Nilesh; Burgess, Diane; Lukacova, Viera

• Mechanistic Evaluation of the Initial Burst Release of Leuprolide from Spray-Dried PLGA Microspheres.

  Schutzman, Richard; Shi, Nianqiu; Olsen, K; Ackermann, Rose; Tang, J; Liu, Ya-Yuan; Hong, Justin; Wang, Yan; Qin, Bin; Schwendeman, Anna; Schwendeman, Steven