Relevance of genetic polymorphism in drug metabolism in the development of new drugs.

Drugs whose principal metabolic pathways are under polymorphic genetic regulation may show considerable interindividual pharmacokinetic variability. This could lead to clinically significant differences in the pharmacological responses of some patients and so might lead the pharmaceutical industry to stop development of the drug. This can be prevented and there are several measures that can be taken to avoid such premature termination of development. They include studies in vitro with human liver samples, and clinical pharmacological experiments designed specifically to examine possible genetic polymorphism in the disposition of the drug.