Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs
Author:
Affiliation:
1. Division of Antiviral Products/Office of Antimicrobial Products; Center for Drug Evaluation and Research; U.S. Food and Drug Administration; Silver Spring MD
Publisher
Wiley
Subject
Hepatology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/hep.27880/fullpdf
Reference25 articles.
1. American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update;Ghany;Hepatology,2009
2. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases;Ghany;Hepatology,2011
3. http://www.hcvguidelines.org
4. ® http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf
5. ® http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s012lbl.pdf
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