ADME pharmacogenetics: current practices and future outlook.
BACKGROUND
Genetic variants of ADME (absorption, distribution, metabolism and elimination) related genes have been consistently associated with pharmacokinetic properties of numerous drugs. However, the association between these genetic markers and clinical outcomes remains controversial.


OBJECTIVE
Inform future pharmacogenetic ADME research and define the terms and practices for the utility of this approach.


METHODS
Review of case studies, where ADME genetic markers have been applied, either successfully or inefficiently. In each case, the level of evidence was examined by reviewing independent, soundly designed reports. The impact on health outcomes that may, or may not, demonstrate clinical utility was also assessed.


CONCLUSIONS
ADME genetic markers can account for clinically relevant variance as related to drug response phenotypes, but scant evidence has been produced thus far to demonstrate their clinical utility. Particularly in the context of drug development, several considerations and practices are suggested, which may guide proper analysis, interpretation and translation into improved healthcare in a cost-effective fashion.
Grossman
Iris
I
Pharmacogenetics Consulting, Cabernet Pharmaceuticals, Inc., R. David Thomas Center, One Science Drive, BOX 90344, Durham, NC 27708, USA. irisg@cabernetpharma.com
D000818:Animals; D003362:Cost-Benefit Analysis; D015195:Drug Design; D005819:Genetic Markers; D006801:Humans; D010597:Pharmacogenetics / Q000191:economics; D010599:Pharmacokinetics; D010641:Phenotype
D005819:Genetic Markers