[The relevance of biomarkers for personalised medicine].

In this paper the relevance of biomarkers for the benefit/risk assessment of pharmaceuticals and the validation of biomarkers within clinical trials is presented. For this purpose the most important study designs for validation are described and discussed. Using the example of the development of rosuvastatin and the validation of hs-CRP (JUPITER study), aspects that are necessary for the planning of a joint development program for a pharmaceutical drug and a biomarker are discussed. In addition, alternatives considering how the validation of the biomarker could be involved in the entire development program of the pharmaceutical drug are presented.