Ontogeny and the Application of Pharmacogenomics to Pediatric Drug Development

Drug product labels are important vehicles for conveying the scientific information needed for the safe and effective use of a medicinal product. Increasingly, pharmacogenomic (PGx) information is being incorporated into US Food and Drug Administration-approved product labels. In the majority of cases, the PGx information in labeling is derived from studies in adults. Observed genotype-phenotype relationships in adults may not always be reflective of those in certain pediatric age groups because of the influence of ontogeny. The quantitative data necessary for modeling certain genomic markers in pediatrics is still lacking, and further research focused on generating this is needed. In addition, drug safety research focused on understanding the potential contributions of ontogeny, PGx and other underlying mechanisms to differences in adverse drug reactions between pediatrics and adults is warranted.