Carcinogenicity

For products where prolonged or lifetime exposure may occur in humans, it is always necessary to consider performing carcinogenicity studies. LAB Research has the experience and expertise in performing these studies. 

Disciplines
LAB Research routinely performs these studies using all of the standard guidelines, including those of the EU (CPMP), ICH, FDA, EPA, JMHW, JMAFF and OECD. The basic design of the study is similar for all of these guidelines, although for agrochemicals and industrial chemicals it is possible to combine one of the carcinogenicity studies with the long-term chronic toxicity study.

Speciality Services
In the ICH guideline S1B, the possibility of using alternative models for carcinogenicity testing is described. An extensive evaluation of these models was performed under the auspices of the International Life Sciences Institute (ILSI) of the Health and Environmental Sciences Institute (HESI), Washington DC. The use of some of these models is becoming more common, particularly for submissions to the US FDA.

LAB Research has been very active in the evaluation of these models as part of the ILSI program.

LAB Research can offer all of the following models:

•  p53+/- mouse model
• Tg.AC mouse model
• Tg.rasH2 mouse model
• Neonatal mouse model