Affiliation: Food and Drug Administration
- Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjectsJiang 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...
- Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approvalJiang 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...
- Interferon responsiveness does not change in treatment-experienced hepatitis C subjects: implications for drug development and clinical decisionsJiang 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....