Applications of Biomarkers for Drug Development

Biomarkers and assays based on biomarkers are being used increasingly in the drug development process. The following applications of biomarkers are relevant to drug development (Salter and Holland 2014):

  • • Predictive biomarkers can be used to matching the most appropriate therapy to the mechanism of action for optimal benefit and to identify patients at risk of particular adverse events.
  • • Disease activity biomarkers allow an assessment of the current severity of disease and therefore, response to treatment.
  • • Drug effect biomarkers indicate target engagement and the generation of pharmacological effect of a drug. These biomarkers are useful for determining the required dose and regimen for a new medicine where effects in humans can be compared with effects in the preclinical experiments on disease models.
  • • Drug kinetics biomarkers are genetic variants in drug metabolizing enzymes and drug transporters to indicate causes of adverse drug effects and/or lack of drug efficacy.

Use of surrogate biomarkers was described in Chap. 1. The focus of here will be on the use of biomarkers in clinical trials.

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