Jiang Liu

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects
    Jiang Liu
    Division of Pharmacometrics, US Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Hepatology 57:897-902. 2013
  2. pmc Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approval
    Jiang Liu
    Division of Pharmacometrics, Office of Clinical Pharmacology, CDER, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    AAPS J 15:407-14. 2013
  3. doi request reprint Interferon responsiveness does not change in treatment-experienced hepatitis C subjects: implications for drug development and clinical decisions
    Jiang Liu
    Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Antimicrobial Products, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Infect Dis 55:639-44. 2012

Detail Information

Publications3

  1. doi request reprint Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects
    Jiang Liu
    Division of Pharmacometrics, US Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Hepatology 57:897-902. 2013
    ..The comparability in interferon responsiveness across treatment courses allowed us to bridge data between treatment-naïve and P/R-experienced subjects to support the approval of RGT in prior relapse subjects...
  2. pmc Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approval
    Jiang Liu
    Division of Pharmacometrics, Office of Clinical Pharmacology, CDER, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    AAPS J 15:407-14. 2013
    ..The pharmaceutical industry and the regulatory agencies are equally responsible for using the appropriate methods of primary analysis and providing justification in the protocol...
  3. doi request reprint Interferon responsiveness does not change in treatment-experienced hepatitis C subjects: implications for drug development and clinical decisions
    Jiang Liu
    Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Antimicrobial Products, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Infect Dis 55:639-44. 2012
    ....