Safety pharmacology is the study of the potential undesirable pharmacodynamic effects of a substance in relation to dosage within the substance's therapeutic range and above. In particular, for the medicinal products targeting the immune system, the potential unintended effects should be investigated, e.g. using the in-vitro studies, including the human material. The animal models that are thought to be similar to the human disease may provide further insight in the pharmacological action, the pharmacokinetics, and dosing in the patients. They may also help in safety determination.
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Considerations
The following factors have to be considered:
Study design
Safety pharmacology studies have to be designed for defining the dose-response relationship of the adverse effect observed. The time course (e.g., onset and duration of response) of the adverse effect has to be investigated. Generally, the doses eliciting the adverse effect have to be compared to the doses eliciting the primary pharmacodynamic effect in the test species or the proposed therapeutic effect in humans.