Specific toxicology approaches

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Non-clinical requirements apply to all medicinal products submitted for marketing authorisation. However, non-clinical models and methods (in vitro and in vivo) may have to be adapted due to the specificity of the medicinal product, its mechanism of action and the relevance or availability of non-clinical models of methods.

The goal of the non-clinical development is to ensure the safe use of medicinal products in humans while limiting the use of animals and preserving the environment as much as possible.

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