ABSTRACT
Cancer is characterised by an unrestricted proliferation of cells, which eventually will go beyond the limits of the organs from which they originate. To start a chapter on carcinogenicity testing of human pharmaceuticals, the authors should first learn about the relationship between chemical or biological compounds and cancer. It is generally accepted that cancer is initiated by DNA damage and genetic instability. A long-term safety issue for human pharmaceuticals is the potential for cancer-causing properties, and this is covered by the pharmaceutical legislation in all parts of the world. A study in 1991, summarising the data of the National Toxicology Program, indicated that 53% of 301 chemicals scored positive in rodent carcinogenicity assays, and 40% of those were classified as non-genotoxic. With the breakthrough of the recombinant DNA techniques to synthesise natural peptide hormones, such as growth factors and insulins, new possibilities came on the horizon of pharmaceutical development.
