The role of carcinogenicity studies in risk assessment

  • E. Fröhlich
  • R. Hess
Conference paper

Abstract

Until recently, most of the controversy about carcinogenicity testing and long-term safety has been concerned with food additives and environmental chemicals rather than with drugs. However, in medicine, cytotoxic drugs or photochemotherapy are used with increasing frequency for the treatment of non-malignant disorders. The occurrence of malignancy in spontaneous or induced immunodeficiency disease has also become a more frequent finding. This has opened the view to possible long-term consequences of certain forms of chemotherapy. Furthermore, for drugs in general which are intended for longer-term use, the question of carcinogenicity has become, from the regulatory point of view, most decisive for the fate of a new product.

Keywords

Toxicology Weinstein Carcinogenicity 

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Copyright information

© Springer-Verlag Berlin Heidelberg 1985

Authors and Affiliations

  • E. Fröhlich
    • 1
  • R. Hess
  1. 1.Toxicology Ciba-GeigyBaselSwitzerland

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