Safety pharmacology

The safety pharmacology studies are defined as those studies which investigate the potential undesirable pharmacodynamic effects of a substance on the functions in relation to the exposure in the 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 the determination of the safety.

The following factors have to be considered:
* The results from the previous safety pharmacology studies.
* The effects related to the therapeutic effects of the test substance.
* The Adverse effects associated with the members of the chemical or therapeutic effect.
* The ligand binding or enzyme assay data suggesting a potential for the adverse effects.

The 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 the humans.

References

1. AR Waladkhani. (2008). Conducting clinical trials. A theoretical and practical guide.ISBN 9783940934000