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(272)
• Posters(124)
• Presentations(72)
• Papers(76)

• Method Matters: Development of characterization techniques for branched and glucose-poly(lactide-co-glycolide) polymers

  Hadar, Justin; Skidmore, Sarah; Garner, John; Park, Haesun; Park, Kinam; Wang, Yan; Qin, Bin; Jiang, Xiaohui; Kozak, Darby

• Drug Release Testing of Long-Acting Intrauterine Systems

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

• Effect of Implant Formation on Drug Release Kinetics of In Situ Forming Implants

  Suh, Min Sung; Kastellorizios, Michail; Tipnis, Namita; Zou, Yuan; Wang, Yan; Choi, Stephanie; Burgess, Diane

• Evaluating and Reporting the Immunogenicity Impacts for Biological Products–a Clinical Pharmacology Perspective

  Wang, Yowming; Wang, Jie; Hon, Yuenyi; Zhou, Lin; Fang, Lanyan; Ahn, Hae Young

• Assessing Microstructural Critical Quality Attributes in PLGA Microspheres by FIB-SEM Analytics

  Clark, Andrew; Wang, Ruifeng; Qin, Yuri; Wang, Yan; Zhu, Aiden; Lomeo, Joshua; Bao, Quanying; Burgess, Diane; Chen, Jacie; Qin, Bin; Zou, Yuan; Zhang, Shawn

• Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products: Summary of Workshop

  Gong, Yuqing; Zhang, Peijue; Yoon, Miyoung; Zhu, Hao; Kohojkar, Ameya; Hooker, Andrew; Ducharme, Murray; Gobburu, Jogarao; Celliere, Geraldine; Gajjar, Parmesh; Li, Bing; Velagapudi, Raja; Tsang, Yu Chung; Schwendeman, Anna; Poli, James; Fang, Lanyan; Lionberger, Robert; Zhao, Liang

• Generating Model-integrated Evidence for Developing and Approving Complex Generic LAI Products

  Zhao, Liang

• Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals

  Zhao, Liang

• Generating Model-integrated Evidence for Developing & Approving Complex Generic LAI Products.

  Zhao, L

• Image-Based Porosity, Density, and In Silico Modeling for Product Equivalence Assessment

  Zhang, Shawn