3. Non-clinical studies: Ability to predict studies in humans

Historically, there have been challenges as to how suited non-clinical studies are to predict human studies (also referred to as their predictive value). These challenges have been related to pharmacokinetics, pharmacodynamics (efficacy), and safety in humans which are difficult to predict in non-clinical studies. There is a rapid development in this area. Many new technologies in silico (computer models), pharmacogenomics, biomarkers, and new exploratory designs for clinical trials are being developed. They all have a positive influence on the predictive value of non-clinical studies.