Carcinogenicity Studies
Evaluate the tumorigenic potential of new compounds with our comprehensive carcinogenicity testing. Our expert studies meet strict regulatory standards, ensuring your compounds undergo thorough and reliable safety assessment that advances development and compliance.
Square Feet of Lab Testing Space
Environmentally Controlled Animal Rooms
Safety Assessment Studies Conducted/Year
Carcinogenicity Testing
Services & Models
We offer a range of testing models, including rodent bioassays and in vitro options, to fit your compound’s specific requirements. Our experts guide you through choosing the most predictive models to deliver accurate, actionable data on carcinogenic risk.
- Alignment with FDA, OECD, and ICH regulatory guidelines
- Customized to your compound and goals
- Early risk identification for safer drug development
- Tailored guidance on testing models and methods
- Early-stage in vitro testing for quick insights
- Rodent models for comprehensive, validated data
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.
Understanding Your Testing 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 to design the best carcinogenicity testing program for your needs.
Carcinogenicity Testing FAQs
What is the purpose of carcinogenicity testing?
To determine the risk of long-term pharmaceutical use in humans, regulatory guidelines first require carcinogenicity testing to identify tumorigenic potential in animals. Carcinogenicity testing identifies whether a compound has the potential to cause cancer, ensuring its safety in humans.
How does carcinogenicity testing work?
Carcinogenicity 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.
What does carcinogenicity testing include?
Elements of a carcinogenicity study include model selection, administration route, dose level, housing and feeding, endpoints, and pathology.
What types of carcinogenicity tests do you offer?
We offer rodent bioassays, in vitro models, and customized studies to assess carcinogenic potential at various stages.
How long does a carcinogenicity study take?
Depending on the model, studies can range from several weeks to two years, with long-term rodent studies often being lengthier.
Which regulatory guidelines your carcinogenicity studies comply with?
Our studies comply with GLP, ICH, FDA, and OECD standards to ensure regulatory acceptance.
Do you provide histopathological analysis in your studies?
Yes, our studies include histopathology to detect tumors and other abnormalities.
Can you develop customized study designs?
Yes. We tailor study designs to meet specific compound properties and regulatory needs.
What species do you use in your studies?
Common species include rodents, but selection varies based on regulatory guidance and compound requirements.
What kind of reports do you provide?
We provide comprehensive, regulatory-compliant reports with detailed findings and risk assessments for decision-making.
How are doses determined for each study?
Doses are selected based on regulatory guidelines and preclinical data to achieve meaningful and reproducible results.