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

• 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

• An Automated Electroanalytical Method for the Drug Release Profiling of Liposomal Doxorubicin HCl Formulations

  Yurtsever, Fatma; Jiang, Wenlei; Mudalige, Thilak

• Evaluation of Size-Based Distribution of Components in VYXEOS� Liposomal Formulation using Asymmetric Flow Field-Flow Fractionation

  Siriwardane, Dumindika; Shakiba, Sheyda; Jiang, Wenlei; Mudalige, Thilak

• Development of an Accelerated Rotator-based Drug Release Method for the Evaluation of Bupivacaine Multivesicular Liposomes

  Xia, Ziyun; Yu, Minzhi; Liu, Yayuan; Yuan, Wenmin; Wang, Yan; Xu, Xiaoming; Bae, Jungeun; Schwendeman, Anna

• Excipient-related Impurities in Liposome Drug Products

  Wang, Changguang; Gamage, Prabhath; Jiang, Wenlei; Mudalige, Thilak

• Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables

  Silva, Daniela A; Le Merdy, Maxime; Alam, Khondoker; Wang, Yan; Bao, Quanying; Malavia, Nilesh; Burgess, Diane; Lukacova, Viera