international council for harmonisation

What Are Some Key ICH Guidelines in Toxicology?

Among the most influential guidelines, the ICH S1 series focuses on carcinogenicity studies, while the ICH S2 guidelines address genotoxicity. The ICH S5 guidelines pertain to reproductive toxicology and teratogenicity studies. Each of these guidelines provides detailed methodologies and criteria for evaluating the potential toxic effects of new drugs, ensuring that the data generated are robust and reliable.

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