EMEA: Concept paper on the Development of a guideline on the use of Pharmacogenomics in the Pharmacokinetic Evaluation of medicinal products

A Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products (EMEA/128517/2006) was published by the EMEA in May 2007. Since the drafting of this Reflection paper, progress in the field has been considerable. In light of the evolution and broad acceptance of genotyping methods, as well as increased experience in the use of such pharmacogenomic methodologies during drug development, it was considered appropriate to update and align this progress in a Guideline on this topic.

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