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)

• Comparison of In-Vitro and In-Vivo Drug Release of Dexamethasone/PLGA Intravitreal Implants Using Two In-Vitro Release Methods and a Rabbit Model

  Johnson, Coleman; Maier, Esther; Bhalla, Aanya; Crowell, Eric; Wang, Yan; Qin, Bin; Zhang, Feng

• Understanding Drug Release Mechanisms of Risperidone In Situ Forming Implant Depots in Rabbits

  Wang, Xiaoyi; Wang, Ruifeng; Roy, Mckenzie; Wang, Yan; Qin, Bin; Burgess, Diane J

• Mechanistic Modeling of Intramuscular Administration of a Long-acting Injectable Accounting for Tissue Response At the Depot Site

  Silva, Daniela A; Le Merdy, Maxime; Mullin, James; Malavia, Nilesh; Alam, Khondoker; Tsakalozou, Eleftheria; Al Shoyaib, Abdullah; Wang, Yan; Burgess, Diane; Lukacova, Viera

• Correlation Between Material, Structure, and Drug Release of Nexplanon®: An Ethylene Vinyl Acetate (EVA) Based Long-Acting Implant

  Zhong, Ziyue; Ren, Angela; Doluisio, Nicholas; Smith, William; Qin, Bin; Wang, Yan; Zhang, Feng

• The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/AAPS conference

  Schug, B; Beuerle, G; Bilensoy, E; Cook, J; Fernandes, E; Haertter, S; Kuribayashi, R; Mehta, M; Paixao, P; Seidlitz, A; Tampal, N; Tsang, Y-C; Walstab, J; Wedemeyer, R; Welink, J; Jiang, W

• Characterization of the Repeat Unit Sequence of Poly(lactide-co-glycolide)

  Kuehster, Louis; Bingham, Michael; Dai, Jingyi; Jhon, Young Kuk; Wang, Yan; Qin, Bin; Smith, William C; Xu, Xiaoming; Zhang, Feng; and Lynd, Nathaniel A

• Aging-induced microstructural evolution in risperidone loaded PLGA microspheres

  Clark, Andrew; Wong, Jeffrey; Wang, Ruifeng; Wang, Yan; Qin, Bin; Burgess, Diane; Zhang, Shawn

• In Vitro-In Vivo Relationship and Microstructural Insights into Long-Acting Levonorgestrel Intrauterine Systems

  Suraj Fanse, Andrew Clark, Quanying Bao, Ashwin Abhang, Kellen Maurus, Yuan Zou, Yan Wang, Shawn Zhang, Diane J Burgess

• Understanding the Impact of Accelerated Release Testing Conditions on Physicochemical Properties and Drug Release Mechanisms from Etonogestrel Implants based on Ethylene Vinyl Acetate

  Ren, Angela; Zhong, Ziyue; Magaw, Maggie; Wang, Yan; Qin, Bin; Smith, William; Xu, Xiaoming; Listro, Tony; Zhang, Feng

• Investigation of the Thermal Stability and Hydrolytic Degradation Kinetics of Poly(lactide-co-glycolide) Melts

  Chen, Bebei; Costello, Mark A; Kuehster, Louise; Lynd, Nathaniel A; Qin, Bin; Wang, Yan; Zhang, Feng