Johnson Trevor N
Simcyp Ltd, Blades Enterprise Centre, John Street, Sheffield S2 4SU, UK.
Br J Clin Pharmacol. 2005 Jun;59(6):663-9. doi: 10.1111/j.1365-2125.2005.02429.x.
Most of the drugs on the market are originally developed for adults and dosage selection is based on an optimal balance between clinical efficacy and safety. The aphorism 'children are not small adults' not only holds true for the selection of suitable drugs and dosages for use in children but also their susceptibility to adverse drug reactions. Since children may not be subject to dose escalation studies similar to those carried out in the adult population, some initial estimation of dose in paediatrics should be obtained via extrapolation approaches. However, following such an exercise, well-conducted PK-PD or PK studies will still be needed to determine the most appropriate doses for neonates, infants, children and adolescents.
市场上的大多数药物最初是为成年人开发的，剂量选择基于临床疗效和安全性之间的最佳平衡。“儿童不是小大人”这句格言不仅适用于为儿童选择合适的药物和剂量，也适用于他们对药物不良反应的易感性。由于儿童可能无法像成人那样进行剂量递增研究，因此儿科剂量的一些初步估计应通过外推法获得。然而，在进行这样的操作之后，仍然需要进行良好的药代动力学-药效学（PK-PD）或药代动力学（PK）研究，以确定新生儿、婴儿、儿童和青少年的最合适剂量。
