Neonatal and Pediatric Clinical Pharmacology Preface
Division of Pediatric Clinical Pharmacology, Children's National Medical Center, Sheikh Zayed Campus for Advanced Children's Medicine, GWU School of Medicine and Health Sciences, 111 Michigan Avenue, NW, Washington, DC 20010, USA. Electronic address: .Pediatric Clinics of North America (Impact Factor: 2.2). 10/2012; 59(5):xv-xviii. DOI: 10.1016/j.pcl.2012.07.014
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ABSTRACT: Many drugs are unlicensed in children and consequently their doses have been scaled down from those used in adults. To compare the performance of three scaling models in predicting maintenance doses for children from those used in adults. Three scaling models based on body weight (BW), body surface area (BSA) and BW(0.75) were used to predict maintenance doses across the paediatric age band from the equivalent adult doses for 30 different drugs. The predicted doses were compared with those in the British National Formulary for children 2006 (BNFc). Percentage error and mean squared prediction error were used as a measure of precision, and mean prediction error was used as a measure of bias. In the 1-month and 12-month age groups, the different approaches ranked on their bias (least bias first) were BW<BW(0.75)<BSA and on their precision (most precise first) were BW>BW(0.75)>BSA. The BSA and BW(0.75) methods predicted doses up to 2.86-fold higher than the BNFc in the 1-month and 1-year age group. In the 7-year and 12-year age groups, BW(0.75) and BSA performed better than BW for precision and bias, and no predictions were more than 1.8-fold higher than the BNFc. The BW method tended to also under-predict dose across the paediatric age range. Dose scaling should only be used as a last resort for determining a suitable dose in children. No single method was suitable across the entire paediatric age range.Archives of Disease in Childhood 04/2008; 93(3):207-11. DOI:10.1136/adc.2006.114835
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ABSTRACT: 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.The Journal of Clinical Pharmacology 02/2010; 50(12):1377-87. DOI:10.1177/0091270009360533
- Pediatrics 10/1999; 104(3 Pt 2):644-5.
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