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FY2016 Regulatory Science Report: Nano Drug Products: Clinical Pharmacology and In Vivo Correlation

This section contains only new information from FY2016.  For background scientific information and outcomes from previous years on this research topic, please refer to the FY15 Regulatory Science Research Report on Nano Drug Products: Clinical Pharmacology and In Vivo Correlation.

ORS staff facilitating research in this area

  • Dajun Sun, Lanyan (Lucy) Fang, Hong Wen, Xinyuan Zhang, Zhichuan Li, Wenlei Jiang, and other ORS staff

Projects and Collaborators

  • Evaluation of Dissolution Methods for Complex Parenteral Liposomal Formulations
    • Site PI: Bradley Anderson (University of Kentucky)
    • Grant/Contract #: 1 U01 FD004892-01
  • Development of a Liposome Doxorubicin Product Drug Release Assay
    • Site PI: Peter Working (ZoneOne Pharma, Inc.)
    • Grant/Contract #: 1 U01 FD004893-01
  • An in vitro-in vivo correlation model to predict serum non-transferrin bound iron
    • Site PI: Amy Barton Pai (Albany College of Pharmacy and Health Sciences)
    • Grant/Contract #: 1 U01 FD004889-01
  • Evaluation of In Vitro Release Methods for Liposomal Amphotericin B
    • Site PI: Peter Working (ZoneOne Pharma, Inc.)
    • Grant/Contract #: 1 U01 FD005249-01
  • Evaluation of Iron Species in Healthy Subjects Treated with Generic and Reference Sodium Ferric Gluconate
    • Site PI: Sarah Michel (University of Maryland)
    • Grant/Contract #: 1 U01 FD005266-01
  • Internal Project: Determining the biodistribution of colloidal iron products in rats
    • FDA Collaborators: Rodney Rouse and Vikram Patel
    • FDA Center/Office/Division: FDA/CDER/OTS/OCP/DARS

Publications and Presentations

  • Wu M, Sun D, Tyner K, Jiang W, Rouse R. Comparative In Vitro Cellular Uptake Study on Reference and Generic Sodium Ferric Gluconate in Mononuclear Phagocyte Systems. The New York Academy of Sciences Workshop: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges, New York NY (Nov. 9, 2016)
  • Beekman C, Matta M, Mohammad A, Gandhi A, Sun D, Jiang W, Lionberger R, Rouse R. Determining the Bio-distribution of Colloidal Iron Drug Products in Rats by Inductively Coupled Plasma Mass Spectrometry (ICP-MS). The New York Academy of Sciences Workshop: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges, New York NY (Nov. 9, 2016)
  • Matta M, Beekman C, Gandhi A, Rouse R, Patel V. Quantification of Drug Bound Iron, Non-Transferrin Bound Iron, and Total Iron in Serum in a Rat Pharmacokinetic Study. The New York Academy of Sciences Workshop: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges, New York NY (Nov. 9, 2016)
  • New H, Smith A, Brandis J, Williams A, Abdelmalak S, Wilks A, Polli J, Kane M, Ting T, Michel S. Bioanalytical Approaches to Measure Iron Speciation in the Plasma of Patients Treated with Iron-Nanoparticle Drug Products. The New York Academy of Sciences Workshop: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges, New York NY (Nov. 9, 2016)
  • Ye H, Jiang W. Characterization of Paclitaxel and Albumin Oligomeric Status in Abraxane during Storage. The New York Academy of Sciences Workshop: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges, New York NY (Nov. 9, 2016)
  • Yuan W, Kuai R, Dai Z, Yuan Y, Zheng N, Jiang W, Noble C, Hayes M, Szoka FC, Schwendeman A. Development of a Flow-Through USP-4 Apparatus Drug Release Assay to Evaluate Doxorubicin Liposomes. AAPS J [DOI: 10.1208/s12248-016-9958-2] (Aug 2, 2016)

Outcomes

  • Research projects in progress

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