Definition:

This is when animal models are used to predict a drug’s toxicity to humans.

However, animal models may be poor predictors of drug safety in humans.

In drug development, animals have an established place in the regulatory pathway of drugs but the predictability for drug safety remains poor. For toxicity models, animal testing remains acceptable only due to the fact that clear alternatives have not been identified but are increasingly explored.

See also Animal model, efficacy, Animal efficacy rule, Neutropenic mouse model