EMA Publishes Guideline on Use of Pharmacogenetics in Evaluating Pharmacokinetics of Medicines
The guideline clarifies the requirements for the analysis of the effect of genetic variability on the way the human body handles medicines.
The European Medicines Agency has published a guideline advising pharmaceutical companies how to integrate studying the role of genetic variability between patients during the development of medicines.
The guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products clarifies the requirements for the analysis of the effect of genetic variability on the way the human body handles medicines. This includes how 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.
The guideline was adopted by the Committee for Medicinal Products for Human Use after incorporation of comments from the
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