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Carcinogenicity

Toxicology

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.

उदाहरण

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

क्या आप जानते हैं?

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 …