Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection

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Download document Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection
Reference number EMA/446337/2011
Status draft: consultation closed
First published 12/07/2011
Last updated 12/07/2011

Summary

The availability of techniques that facilitate study of the human genome has led to an exponential increase in investigation into genomic biomarkers (GBMs) for diagnosis of specific diseases, as a marker of response to treatment or of prognosis. Theoretically genomic BMs should offer the advantage of improved specificity and reduction of heterogeneity that is an integral part of phenotypic population grouping.