Carcinogenicity studies
The 2-year carcinogenicity study is the gold standard for assessing the long-term cancer-causing potential of pharmaceutical compounds. Conducted primarily in rodents, this study is essential for evaluating tumor incidence and understanding the chronic effects of repeated exposure over a lifespan. At Vivotecnia, we design and execute long-term carcinogenicity studies in full compliance with international guidelines, helping our clients meet regulatory expectations while ensuring scientific integrity and animal welfare.
Preclinical regulatory CRO
Established – 2000
This 2-year study typically involves daily administration of the test compound to rats or mice for 104 weeks. The main objective is to detect neoplastic and preneoplastic lesions, evaluate dose-response relationships, and identify target organs. The data generated supports marketing authorization for chronic use medications and provides crucial insight into human cancer risk. It’s also in line with OECD TG 451 and ICH S1A-S1C guidelines, includes control, low, mid and high dose groups and offers comprehensive pathology, hipathology and statistical analysis.
Pharmaceutical
Chemical
Vivotecnia has a highly specialized bioanalytical unit that combines state-of-the-art technology with a multidisciplinary team of experts in regulated preclinical studies.
Our animal facilities are equipped to manage studies lasting over two years, with environmental controls and monitoring systems tailored for high-standard carcinogenicity programs.
In-house pathology team with experience in tumor diagnosis and grading, ensurign consistency and precision.
Studies designed to meet EMA, FDA, RITA and ICH expectations.
Digital SOPs, real time study tracking, and Provatins platform integration ensure full traceability and data integrity.
Need to assess the long-term
carcinogenicity of your compound?
Let our team help you design and execute
a fully compliant 2-year carcinogenicity
study!
