Preclinical assessment evaluation is a regulatory requirement for human pharmaceuticals as required by the ICH M3(R2) to ensure their are safety before being tested in humans.

Some of the studies are required before the start of in human phases and the results obtained are used to estimate the initial safety starting dose and ranges for human trials. Sub-chronic, chronic or reprotoxicity studies guarantee the safety of the compounds in the species and allow the advancement of clinical studies in humans.  

The studies are designed and conducted under international guidelines (ICH, OECD, EMA, FDA).