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Regulatory Focus™ > News Articles > EMA Publishes Pharmacogenetics Guideline for Evaluation of Medicines

EMA Publishes Pharmacogenetics Guideline for Evaluation of Medicines

Posted 14 February 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) published a new guideline on the use of pharmacogenetics in evaluating pharmacokinetics of medicines on 10 February.

The guideline provides specific requirements and recommendations for designing, conducting, dosing, and evaluating clinical studies. The guideline also discusses how to use information obtained in clinical studies for labeling and treatment recommendations.

The guideline notes that "genetic variation can affect the absorption, distribution, metabolism and excretion of medicines by the body, which can in turn lead to differences in the benefits and risks of a medicine between individuals."

Comments on the guideline are due by 1 August 2012.


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