Protein therapeutics: new applications for pharmacogenetics.

Pharmacogenetic studies have traditionally focused on genes involved in processes that affect the pharmacokinetics of small-molecule drugs, such as drug metabolism. However, attention is shifting to the effects of genetic variations in drug targets and associated pathway components on drug responses. We describe how these variations are important for understanding differences in responses to the growing number of protein therapeutics that are entering clinical practice. Pharmacogenetic studies of these drugs are surveyed, and issues important to the success of such endeavours are discussed. As novel protein therapeutics are introduced, we anticipate that the use of pharmacogenetics will assume a key role in their development and clinical application.