[The relevance of biomarkers for personalised medicine].

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  • Author(s): Großhennig A;Großhennig A; Benda N; Koch A
  • Source:
    Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz [Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz] 2013 Nov; Vol. 56 (11), pp. 1480-8.
  • Publication Type:
    Journal Article
  • Language:
    German
  • Additional Information
    • Transliterated Title:
      Die Bedeutung von Biomarkern für eine personalisierte Medizin.
    • Source:
      Publisher: Springer Country of Publication: Germany NLM ID: 101181368 Publication Model: Print Cited Medium: Internet ISSN: 1437-1588 (Electronic) Linking ISSN: 14369990 NLM ISO Abbreviation: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Subsets: MEDLINE
    • Publication Information:
      Original Publication: Berlin : Springer,
    • Subject Terms:
      Biomarkers/*analysis ; Clinical Trials as Topic/*methods ; Drug Monitoring/*methods ; Outcome Assessment, Health Care/*methods ; Pathology, Molecular/*methods ; Pharmacogenetics/*methods ; Precision Medicine/*methods; Humans ; Risk Assessment/methods
    • Abstract:
      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.
    • Accession Number:
      0 (Biomarkers)
    • Publication Date:
      Date Created: 20131003 Date Completed: 20140521 Latest Revision: 20220408
    • Publication Date:
      20231215
    • Accession Number:
      10.1007/s00103-013-1828-9
    • Accession Number:
      24084852