期刊
JOURNAL OF CLINICAL PHARMACOLOGY
卷 50, 期 12, 页码 1377-1387出版社
SAGE PUBLICATIONS INC
DOI: 10.1177/0091270009360533
关键词
Ontogeny; pediatrics; personalized medicine; pharmacogenetics; pharmacogenomics; drug development; children; regulatory science
资金
- National Institute of Child Health and Human Development (NICHD) [1R03HD36783, 5U01HD031313, 5U01HD045993, 5R01HD048689]
Understanding the dose-exposure-response relationship across the pediatric age spectrum from preterm and term newborns to infants, children, adolescents, and adults is a major challenge for clinicians, pharmaceutical companies, and regulatory agencies. Over the past 3 decades, clinical investigations of many drugs commonly used in pediatric therapeutics have provided valuable insights into age-associated differences in drug disposition and action. However, our understanding of the contribution of genetic variation to variability in drug disposition and response in children generally has lagged behind that of adults. This article proposes a systematic approach that can be used to assess the relative contributions of ontogeny and genetic variation for a given compound. Application of the strategy is illustrated using the current regulatory dilemma posed by the safety and effectiveness of over-the-counter cough and cold remedies as an example. The results of the analysis can be used to aid in the design of studies to yield maximally informative data in pediatric populations of different ages and developmental stages and thereby improve the efficiency of study design.
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