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Opportunities and limitations: the value of pharmacogenetics in clinical practice.

There is wide discussion on the impact and benefit of pharmacogenetic biomarkers but also increasing evidence that the situation is much more complex than anticipated one or two decades ago. Modern pharmacogenomics/pharmacogenetics is related not only to germline genetic variation but to an entire range of molecular traits involved in pharmacokinetics and dynamics which may influence both drug efficacy and safety. This increasing and more complex knowledge requires new diagnostic technologies, new approaches to design of clinical studies combined with appropriate data analyses for the complex data likely to be generated and finally new approaches from international drug regulators. This themed issue aims to summarize the current state of the art of major clinical areas where pharmacogenetics play a substantial role, discusses fields where genetic traits still need to be considered more carefully, outlines modern approaches to data analysis and finally a change of regulatory decision making. The articles in the issue cover a range of areas including a description of an already implemented example of pharmacogenetic testing where some issues remain, reports on several examples where pharmacogenetic testing is possible but its benefit is still controversial and the areas of greatest complexity such as pharmacoepigenetics and systems pharmacology which are still far removed from clinical implementation.