Table 2. Role of biomarkers
| Research/preclinical phase |
| end point marker in animal studies |
| proof of concept testing |
| screening tool for leads |
| rank compounds in portfolio |
| pharmacodynamic evaluation |
| toxicity profile |
| Clinical phase |
| early detection |
| differential diagnosis |
| identify subpopulations for clinical study |
| type/location of injury |
| mechanism of disease, mechanism of action |
| predict severity and prognosis, regression, etc. |
| Surrogate end point |
| drug effect, dose ranging studies |
| focused hypothesis may shorten and decrease size of trial |
| speed agents through testing and approval process |
| Commercial phase |
| test to aid drug dosing |