Carcinogenicity Testing

Assessing Risk

To determine the risk of long-term pharmaceutical use in humans, regulatory guidelines first require carcinogenicity testing to identify tumorigenic potential in animals. These studies expose animals to the test compound for a major portion of their lifespan and assess for the development of non-neoplastic and neoplastic lesions in organs and organ systems.

Elements of a carcinogenicity study include:

• Model selection
• Administration route
• Dose level
• Housing and feeding
• Endpoints
• Pathology

Benefits of the rasH2 Alternative Transgenic Model

Regulatory agencies routinely approve use of the rasH2 transgenic mouse model for carcinogenicity testing in place of a two-year mouse carcinogenicity study. It requires fewer animal resources, can be done faster, and reduces cost.

Understand Your Options

Since carcinogenicity studies are time consuming and resource intensive, they should be performed only when human exposure warrants the need for information from lifetime studies in animals. Fortunately there are options. Our team will help you fully explore and understand the options, and design the best carcinogenicity testing program for your needs.