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Safety Assessment of Antiviral Drugs

  • Elaine C. Esber
  • Robert C. Nelson
  • Norma Jean Browder
Conference paper
Part of the NATO ASI Series book series (NSSA, volume 143)

Abstract

Over the past two decades, accumulating knowledge of viral replication and viral/host cell interaction has made it possible to define virus specific events that are unique and to identify compounds that have the potential to interfere with these events. The available new antiviral agents have already impacted upon the treatment of several viral illnesses and more are under development. With the advent of compounds that interrupt or interfere with events at the genomic level, questions have been raised regarding the safety of these compounds as well as the adequacy of the available test systems to evaluate safety. Just as the field of antiviral drug therapy is young and evolving, so too are the methods used to assess their associated risk.

Keywords

Thymidine Kinase Nucleoside Analogue Antiviral Drug Drug Resistant Mutant Preclinical Testing 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    V. Glockin, Toxicology in Drug Development, Presented at the American Chemical Society Symposium on Toxicology and Risk Assessment (1982).Google Scholar
  2. 2.
    New Drug, Antibiotic, and Biologic, Drug Product Regulations, Federal Register, Vol. 52, No. 53, pp. 8798–8847, March 19, 1987.Google Scholar
  3. 3.
    E.I. Goldenthal, Current Views on Safety Evaluation of Drugs, FDA Papers, May 1968 (GPO: 1970–396–012175).Google Scholar
  4. 4.
    Zovirax, Burroughs Wellcome Co., Research Triangle Park, North Carolina, United States.Google Scholar

Copyright information

© Plenum Press, New York 1988

Authors and Affiliations

  • Elaine C. Esber
    • 1
  • Robert C. Nelson
    • 1
  • Norma Jean Browder
    • 1
  1. 1.Office of Biologics Research and ReviewCenter for Drugs and Biologics, FDARockvilleUSA

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