Pharmacogenomic Biomarkers

Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection

Relevance of ‘missing heritability’ in pharmacogenomics

Pharmacogenomic biomarkers can optimize an individual’s therapy; however, the overall role of genetic factors in drug response remains uncertain. The majority of genetic variants currently used as clinical pharmacogenomic biomarkers affect drug metabolism and transport, while fewer biomarkers accurately predict drug response (pharmacodynamics). This article evaluates heritable aspects of drug t...

Characterizing the Strength of Evidence in FDA Labels for Pharmacogenomic Biomarker-Guided Medication Use

There is great heterogeneity in drug treatment response that is thought to be due to individual-level allelic variation in pharmacogenomic biomarkers. FDA Drug Labels provide information to guide pharmacogenomic biomarker use. Yet, the strength of evidence for clinical validity and clinical utility is lacking. We characterized the strength of evidence and treatment recommendations contained in ...

A European Spectrum of Pharmacogenomic Biomarkers: Implications for Clinical Pharmacogenomics

Pharmacogenomics aims to correlate inter-individual differences of drug efficacy and/or toxicity with the underlying genetic composition, particularly in genes encoding for protein factors and enzymes involved in drug metabolism and transport. In several European populations, particularly in countries with lower income, information related to the prevalence of pharmacogenomic biomarkers is inco...

Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.

STUDY OBJECTIVES To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling. DESIGN Retrospective analysis. DATA SOURCES The Physicians' Desk Reference Web sit...

Role of pharmacogenomic biomarkers in predicting and improving drug response: part 1: the clinical significance of pharmacogenetic variants.

As genotyping and genetic testing become more sophisticated, accessible, and costeffective, these tools hold great promise for predicting and improving responses to medications.