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.
-
Model-Integrated Evidence for Bioequivalence Assessment of Long-Acting Injectables from a Generic Drug Perspective
Yoon, Miyoung
-
Generic Drug Regulatory Research: In Vitro Equivalence Testing
Choi, Stephanie
-
IVRT Method Development for API Suspension Products and Validation with In Vivo Models
Burgess, Diane J
-
In Vitro Drug Release from Complex Parenterals and Development of IVIVCs
Burgess, D
-
Generating Model-integrated Evidence for Developing & Approving Complex Generic LAI Products.
Zhao, L
-
Development and Characterization of Composition-Equivalent Formulations to the One-Month Lupron Depot
Zhou, Jia; Walker, Jennifer; Ackermann, Rose; Olsen, Karl; Hong, Justin; Wang, Yan; Jiang, Xiaohui; Schwendeman, Anna; Schwendeman, Steven
-
Reverse Engineering of the one-month Lupron Depot and Development of Q1/Q2 Formulations
Zhou, Jia; Hirota, Keiji; Ackermann, Rose; Walker, Jennifer; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven
-
Reverse Engineering of the one-month Lupron Depot and Development of Q1/Q2 Formulations
Zhou, Jia; Hirota, Keiji; Ackermann, Rose; Walker, Jennifer; Wang, Yan; Choi, Stephanie; Schwendeman, Anna; Schwendeman, Steven
-
Scientific Gap Analysis of Polymeric In Situ Forming Depot Products for the Development of GDUFA Research Projects
Zhang, Qiangnan; Qin, Bin; Wang, Yan; Li, Qi; Kozak, Darby
-
Understanding the Drug Release Mechanism of Long-term Intrauterine Systems
Zaman, Rokon; Smith, William; Park, Jin; Liang, Jing; Feng, Xin; Fan, Zhaobo; Wang, Yan; Zheng, Jiwen; Xu, Xiaoming