• EMA Publishes Pharmacogenetics Guideline for Evaluation of Medicines

    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 ab...
  • EMA Calls for Guidelines on the Use of Pharmacogenomics in Pharmacovigilance Evaluation

    The European Medicines Agency (EMA) issued a concept paper on 23 January that calls for a new guideline to be issued on the use of pharmacogenomics in the conduct of pharmacovigilance. The concept paper notes that the response most individuals have to drug therapy is highly variable, and a prominent component of this variability is related to genetic variations. This can relate to drug disposition (pharmacokinetics) or drug action (pharmacodynamics). Accurate knowledg...