Safety pharmacology studies are defined in the International Conference on Harmonization (ICH) S7A guidance as “those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.” 

In other words, they are a set of tests focused on potentially adverse effects of pharmaceutical or biological agents, differing from traditional toxicology studies as they are typically concentrated on a single organ or physiological system.

In Issue 13 of The Altascientist, we take a look at the requirements, best practices, and core and supplemental study considerations, including:

• Cardiovascular system
• Central nervous system
• Respiratory system
• Species selection
• Routes of administration
• Dose level selection and duration
• Supplemental (follow-up) studies
• Safety pharmacology endpoints on traditional toxicology studies