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(66)
• Posters(18)
• Presentations(27)
• Papers(21)

• 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

• 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

• Orthogonal and Complementary Measurements of Properties of Drug Products Containing Nanomaterials

  Simon, C G; Borgos, S E; Calzolai, L; Nelson, B C; Parot, J; Petersen, E J; Roesslein, M; Xu, X; Caputo, F

• Scanning Electron-Raman Cryomicroscopy for Characterization of Nanoparticle-Albumin Drug Products

  Yilmaz, Huzeyfe; Ahmed, S; Rodriguez, Jason D; Willett, Daniel R

• Topical Pharmacokinetics of Brinzolamide Suspensions in Rabbits and Variability Analysis for Sample Size and Design Considerations

  Naageshwaran, Vatsala; Bigonne, Helene; Gum, Glenwood; Malla, Spundana; Sol, Charity Del; Bon, Charles; Xu, Xiamoning; Vo, Anh; Smith, William; Beringhs, Andre O’reilly; Kozak, Darby; Tan, Mingliang; Babiskin, Andrew; Babiskin, Andrew; Urtti, Arto; Amo, Eva Del; Ranta, Veli Pekka