Preclinical Evaluation of Cancer Hazard and Risk of Biopharmaceuticals

A variety of preclinical approaches have been used for assessing carcinogenic potential of pharmaceuticals. The need for carcinogenicity assessment of a biopharmaceutical is based on an intended duration of, cause for concern, indication, patient population including the nature of the disease and its effect on life span and overall patient health, route and exposure, and extent of systemic exposure. This article focuses on need and various preclinical approaches for preclinical carcinogenicity assessment of biopharmaceuticals. Keywords: carcinogenicity; rodent bioassay; growth factors; gene therapies