What is the Origin of Carcinogenicity Studies?

The need for such rigorous testing arose from historical instances where chronic exposure to certain chemicals was later linked to increased cancer rates. The term is a compound of "carcino-" (Greek for karkinos, meaning tumor) and "-genicity" (the ability to generate). These studies are a cornerstone of modern pharmaceutical development, ensuring a thorough understanding of a drug's long-term safety profile.

What is the Mechanism of Carcinogenicity Studies?

The standard protocol involves administering the test substance at various dose levels to two different species of rodents, typically rats and mice, for the majority of their natural lifespan, often 18 to 24 months. Throughout the study, animals are meticulously monitored for any signs of tumor development. At termination, a comprehensive histopathological examination of all major organs is performed to identify any treatment-related neoplastic lesions, allowing for the determination of a dose-response relationship and the establishment of a no-observed-adverse-effect level (NOAEL).

Carcinogenicity Studies

Meaning

Carcinogenicity Studies are comprehensive, long-term toxicological investigations conducted to assess the potential of a substance, such as a new drug or hormone analog, to induce or accelerate the formation of cancerous tumors. These preclinical studies are a mandatory component of the safety assessment for any compound intended for prolonged administration in humans. The findings provide critical data on oncogenic risk, which directly informs clinical prescribing practices and regulatory approval decisions.