Chronic and Carcinogenicity Studies

We support our clients in defining carcinogenicity testing strategies to meet regulatory requirements by project design and appropriate model selection to determine administration routes and doses.

We conduct carcinogenicity studies in compliance with EU (CPMP), ICH, FDA, EPA, JMHW, JMAFF, and OECD regulations. Requirements are similar for all studies, though the testing of agrochemicals and industrial chemicals can combine carcinogenicity studies with a long-term chronic toxicity study.

Traditional carcinogenicity studies are conducted in Wistar or Sprague-Dawley rats and CD-1 mice for 24- and 18-months duration, respectively.

Transgenic Models

Regulatory authorities such as US FDA, EMA CHMP, and PMDA accept data from short-term mouse study using a transgenic model. A 26-week study in the transgenic Tg.rasH2 mouse model is commonly selected as a replacement for the standard two-year rat or mouse study.

We have evaluated these alternative models and generated significant amounts of historical and published data.