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