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Over the past 3 decades, clinical investigations of many drugs commonly used in pediatric therapeutics have provided valuable insights into age\u2010associated 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\u2010the\u2010counter 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.<\/jats:p>","DOI":"10.1177\/0091270009360533","type":"journal-article","created":{"date-parts":[[2010,2,12]],"date-time":"2010-02-12T03:53:36Z","timestamp":1265946816000},"page":"1377-1387","source":"Crossref","is-referenced-by-count":82,"title":["Understanding the Relative Roles of Pharmacogenetics and Ontogeny in Pediatric Drug Development and Regulatory Science"],"prefix":"10.1002","volume":"50","author":[{"given":"J. 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