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 ros...

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Bibliographic Details
Published in:Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Gesundheitsforschung, Gesundheitsschutz, 2013-11, Vol.56 (11), p.1480-1488
Main Authors: Großhennig, A, Benda, N, Koch, A
Format: Article
Language:ger
Subjects:
Biomarkers - analysis
Clinical Trials as Topic - methods
Drug Monitoring - methods
Humans
Outcome Assessment (Health Care) - methods
Pathology, Molecular - methods
Pharmacogenetics - methods
Precision Medicine - methods
Risk Assessment - methods
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Summary: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.
ISSN:1437-1588
DOI:10.1007/s00103-013-1828-9