GDUFA Research Outcomes

Injectable Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to injectable generic drug products.

• All(148)
• Posters(54)
• Presentations(36)
• Papers(58)

• Injectable, Long-Acting PLGA Formulations: Analyzing PLGA and Understanding Microparticle Formation

  Park, Kinam; Skidmore, Sarah; Hadar, Justin; Garner, John; Park, Haesun; Otte, Andrew; Soh, Bong Kwan; Yoon, Gwangheum; Yu, Dijia; Yun, Yeonhee; Lee, Byung Kook; Jiang, Xiaohui; Wang, Yan

• In-Vitro and In-Vivo Characterizations of Liposomal Doxorubicin HCl Products

  Jiang, Wenlei; Lionberger, Robert; Yu, Lawrence

• Development of a Flow-through USP 4 Apparatus Drug Release Assay for the Evaluation of Amphotericin B Liposome

  Tang, Jie; Srinivasan, Santhanakrishnan; Yuan, Wenmin; Ming, Ran; Liu, Yayuan; Dai, Zhipeng; Noble, Charles; Hayes, Mark; Zheng, Nan; Jiang, Wenlei; Szoka, Francis; Schwendeman, Anna

• A Multiscale Physiologically-Based Pharmacokinetic Model for Doxorubicin to Explore its Mechanisms of Cytotoxicity and Cardiotoxicity in Human Physiological Contexts

  He, Hua; Liu, Can; Wu, Yun; Zhang, Xinyuan; Fan, Jianghong; Cao, Yanguang

• Analysis of Verteporfin Liposomal Formulations for Phospholipids and Phospholipid Degradation Products by Liquid Chromatography-mass Spectrometry (LC-MS)

  Ansar, Siyam; Jiang, Wenlei; Mudalige, Thilak

• Mathematical Modeling of the Heterogeneous Distributions of Nanomedicines in Solid Tumors

  He, Hua; Liu, Can; Liu, Yuhui; Liu, Xiaoquan; Wu, Yun; Fan, Jianghong; Zhao, Liang; Cao, Yanguang

• Development of In Vitro-In Vivo Correlation of Parenteral Naltrexone Loaded Polymeric Microspheres

  Andhariya, Janki; Shen, Jie; Choi, Stephanie; Wang, Yan; Zou, Yuan; Burgess, Diane

• Development of a Flow-through USP-4 Apparatus Drug Release Assay to Evaluate Doxorubicin Liposomes

  Yuan, Wenmin; Kuai, Rui; Dai, Zhipeng; Yuan, Yue; Zheng, Nan; Jiang, Wenlei; Noble, Charles; Hayes, Mark; Szoka, Francis; Schwendeman, Anna

• A Real-Time NMR Method for Measurement of In Vitro Aggregation Kinetics of Degarelix Drug Products

  Patil, Sharadrao; Qin, Bin; Wang, Yan; Ahmed, Snober; Yilmaz, Huzeyfe; Jiang, Xiaohui; Keire, David; Chen, Kang

• Mechanistic Model and Analysis of Doxorubicin Release from Liposomal Formulations

  Fugit, Kyle; Xiang, Tianxiang; Choi, Du; Kangarlou, Sogol; Csuhai, Eva; Bummer, Paul; Anderson, Bradley