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(119)
• Posters(43)
• Presentations(31)
• Papers(45)

• Physiologically Based Pharmacokinetic Modeling of Nanoparticles

  Yuan, Dongfen; He, Hua; Wu, Yun; Fan, Jianghong; Cao, Yanguang

• Determination of Key Parameters for a Mechanism-Based Model to Predict Doxorubicin Release from Actively Loaded Liposomes

  Csuhai, Eva; Kangarlou, Sogol; Xiang, Tianxiang; Ponta, Andrei; Bummer, Paul; Choi, Duhyung; Anderson, Bradley

• 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

• 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

• 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 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