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 model

Animal model

An animal model is a living, non-human animal used during the research and investigation of human disease, for the purpose of better understanding the disease without the added risk of causing harm to an actual human being during the process...

s that are thought to be similar to the human disease may provide further insight in the pharmacological action, the pharmacokinetics

Pharmacokinetics

Pharmacokinetics, sometimes abbreviated as PK, is a branch of pharmacology dedicated to the determination of the fate of substances administered externally to a living organism...

, and dosing in the patients. They may also help in safety determination.

Considerations

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
  Enzyme assay
  Enzyme assays are laboratory methods for measuring enzymatic activity. They are vital for the study of enzyme kinetics and enzyme inhibition.-Enzyme units:...
  
   data suggesting a potential for the adverse effects.

Study design

Safety pharmacology studies have to be designed for defining the dose-response relationship

Dose-response relationship

The dose-response relationship, or exposure-response relationship, describes the change in effect on an organism caused by differing levels of exposure to a stressor after a certain exposure time...

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.