Carcinogenicity

The potential of a substance to induce malignant tumor formation through genotoxic or non-genotoxic mechanisms. Regulatory carcinogenicity studies (ICH S1) are typically 2-year rodent bioassays required for drugs intended for chronic use (>6 months). Non-genotoxic carcinogens may act through hormonal stimulation, immunosuppression, chronic tissue injury, or epigenetic mechanisms.

ตัวอย่าง

• 2-year rat carcinogenicity study for chronic-use drugs
• Pioglitazone and bladder cancer signal
• Tamoxifen endometrial cancer risk via estrogenic activity