Pharmacogenomics is the study of how the variability of the expression of genes between people leads to differences in susceptibility to disease and responses to medicines.
Research into pharmacogenomics began following observations that not all people respond in the same way to the same medicines. This revealed that differences between individuals is caused by their genetic profile, at least in part.
Pharmacogenomics is an important new technology that promises to optimise the use of medicines, by targeting medicines to patient's individual genes. This is called 'personalised medicine'. Many pharmaceutical companies are also now integrating pharmacogenomics into their development strategies for medicines.
Activities at the European Medicines Agency
The European Medicines Agency has a Pharmacogenomics Working Party, a group of European experts in pharmacogenomics that gives recommendations to the Committee for Medicinal Products for Human Use (CHMP).
The Agency also hosts meetings on pharmacogenomics and related areas:
- Report to the Committee on Proprietary Medicinal Products on the European Medicines Agency seminar on the use of pharmacogenetics in the drug development process (05/06/2000)
- European Medicines Agency / European Federation of Pharmaceutical Industries and Associations workshop: Integrating pharmacogenomics early into drug development: Pharmacokinetics as a working example (18/12/2008)
- European Medicines Agency workshop on pharmacogenomics: from science to clinical care (08-09/10/2012)
The Agency also publishes scientific guidelines on pharmacogenomics. These intend to help companies design and carry out studies in pharmacogenomics.
Medicines with pharmacogenetic information
The Department of Genetics at Stanford University maintains a pharmacogenomics knowledge resource called PharmGKB. This resource includes clinical information such as dosing guidelines, published information on medicines, associations between genes and medicines and relationships between genotypes and phenotypes.
Part of this resource lists the European Union (EU)-authorised medicines approved by the EMA that contain pharmacogenetic information in the summary of product characteristics.
- For more information see PharmGKB: Drug labels.
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