international council for harmonisation (ich)

What are ICH Guidelines?


ICH guidelines cover various aspects of drug development and registration, including quality, safety, and efficacy. In the context of toxicology, the safety guidelines are particularly important. These include recommendations on how to conduct non-clinical safety studies, assess carcinogenicity, genotoxicity, and reproductive toxicity, and determine the safe starting dose for human clinical trials. The guidelines ensure that studies are conducted following the best scientific practices, promoting data accuracy and reliability.

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