ICH S3 (Carcinogenicity Studies)

ICH S3 provides guidelines for conducting and evaluating studies that assess whether a drug or chemical could cause cancer. These carcinogenicity studies typically involve long-term tests on animals to observe any development of tumors or cancer over time. The goal is to identify potential cancer risks before medicines or chemicals are marketed, ensuring safety for humans. The guidelines specify how to design, carry out, and interpret these studies reliably. Overall, ICH S3 helps pharmaceutical companies and regulators understand the cancer-causing potential of substances, supporting informed decisions on their safe use.