EMA RELEASES GUIDANCE ON USING PHARMACOGENETICS IN CLINICAL TRIALS
May 1st, 2016
THE EUROPEAN Medicines Agency (EMA) has developed guidance on using genomic biomarkers in clinical trials and other studies, advising on the choice of pharmacogenetics technology.
This work, said EMA’s advice “should follow certain principles in order to generate reliable evidence for decision making and patient treatment.” The guidelines build on earlier International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and EMA’s own advice outlining principles for the regulatory evaluation of genomic biomarkers. ...
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