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.