GDUFA Research Outcomes

Nanotechnology Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to generic products that contain nanomaterials or nanotechnology (e.g., colloidal iron-carbohydrate and liposomal products).

• All(59)
• Posters(15)
• Presentations(25)
• Papers(19)

• Manufacturing Process of Liposomal Formation: a Coarse-Grained Molecular Dynamics Simulation

  Duran, Tibo; Costa, Antonio P; Kneski, Jake; Xu, Xiaoming; Burgess, Diane J; Mohammadiarani, Hossein; Chaudhuri, Boshisattwa

• Intact NMR Approach Quickly Reveals Synchronized Microstructural Changes in Oil-in-Water Nanoemulsion Formulations

  Wang, Deyun; Li, Jiayi; Chen, Kang

• 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

• 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

• 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

• 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