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(140)
• Posters(51)
• Presentations(34)
• Papers(55)

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

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

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

  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

• 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

• Excipient-related Impurities in Liposome Drug Products

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

• In Vitro Lipolysis Model to Predict Food Effect of Poorly Water-Soluble Drugs Itraconazole, Rivaroxaban, and Ritonavir

  Patel, Roshni P; Cristofoletti, Rodrigo; Wu, Fang; Al Shoyaib, Abdullah

• Relative Performance of Volume of Distribution Prediction Methods for Lipophilic Drugs with Uncertainty in LogP Value

  Coutinho, Ana; Cristofoletti, Rodrigo; Wu, Fang; Al Shoyaib, Abdullah; Dressman, Jennifer; Polli, James E

• A Robust, Viable, and Resource Sparing HPLC-based logP Method Applied to Common Drugs

  Coutinho, Ana; Cristofoletti, Rodrigo; Wu, Fang; Shoyaib, Abdullah; Dressman, Jennifer; Polli, James