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)

• 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

• Impact of Agglomeration on In Vitro Performance of Long-Acting Injectable Suspensions

  Malavia, Nilesh; Bao, Quanying; Silva, Daniela Amaral; Wang, Yan; Alam, Khondoker; Lukacova, Viera; Burgess, Diane J

• Leveraging Model Master Files for Long-Acting Injectables

  Gong, Yuqing; Hopefl, Robert; Li, Tonglei; Hooker, Andrew C; Silva, Daniela Amaral; Alam, Khondoker; Ducharme, Murray; Moody, Rebecca; Saha, Pratik; Babiskin, Andrew

• Regulatory Perspectives: Method Validation and Common Deficiencies

  Smith, William

• Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices

  Xu, Xiaoming

• Advanced Characterization of Injectafer®: Carboxymaltose Structure, Iron Core Structure, and Interaction of Carboxymaltose with Iron Core

  Shamim. Md Abdullah; Zhang, Tianyun; Huls, Nicholas; Munson, Eric J; Liu, Dahui; Chen, Kang; Qu, Haiou; Zhang, Li; Jiang, Wenlei; Wang, Yan; Zhang, Deyi

• Impact of Polyethylene Glycol Polymer in the Development of Long-Acting Injectable Suspensions

  Malavia, Nilesh; Bao, Quanying; Silva, Daniela Amaral; Lukacova, Viera; Alam, Khondoker; Wang, Yan; Burgess, Diane J

• Physiologically Based Pharmacokinetic Modeling and Mechanistic In Vitro-In Vivo Correlation for Long-Acting Injectable Suspension

  Silva, Daniela Amaral; Lukacova, Viera; Alam, Khondoker; Tsakalozou, Eleftheria; Al Shoyaib, Abdullah

• An Automated Capillary Electrophoresis Based Method for Drug Release Profiling of Liposomal Doxorubicin

  Jayaraj, Savithra; Jiang, Wenlei; Mudalige, Thilak

• A Robust Chromatographic Method for Drug Release Profiling of Liposomal Doxorubicin HCl

  Niyonshuti, Isabelle I; Jayaraj, Savithra; Jiang, Wenlei; Mudalige, Thilak