ABSTRACT
Introduction Some drugs have been linked to the development of hematological and solid tumors.
The assessment of carcinogenicity of drugs during their development is by in-vitro (genotoxicity) and in-vivo tests. The hazard and risk may vary during the development as more persons are exposed for longer periods of time. According to the International Conference on Harmonization (ICH) Guideline S1A, carcinogenicity studies should be performed for any pharmaceutical where the expected clinical use is continuous for at least 6 months or repeatedly intermittent for chronic conditions. In the development of a new drug, it is also important to consider:
■ previous evidence of carcinogenic potential in the product class relevant to humans
■ a structure-activity relationship that suggests a carcinogenic risk ■ evidence of precancerous lesions in repeated-dose toxicity studies ■ long-term tissue retention of the parent compound or metabolite(s), resulting
in local tissue reactions or other pathophysiological responses.
