School of Pharmacy, De Montfort University, Leicester, UK.
Arch Dis Child. 2010 Jun;95(6):484-7. doi: 10.1136/adc.2009.177592.
Pharmacokinetic data are used to develop dosing regimens for medicines. The dose regimens of many drugs administered to children have historically been based on pharmacokinetic data generated in adults. The 'adult' dose was simply adjusted to the child's body weight or surface area. This practice is potentially unsafe and not acceptable to drug regulatory agencies. Obtaining pharmacokinetic data in children is beset with ethical issues and technical challenges as pharmacokinetic studies require repeated measurement of drug levels in blood. Dried blood spot (DBS) samples used in conjunction with population pharmacokinetic modelling techniques is one potential method for performing pharmacokinetic studies in children. In this article, we review the DBS technique for performing pharmacokinetic studies and highlight issues that still need to be addressed to establish DBS as a method for performing pharmacokinetic studies in children.
药代动力学数据用于制定药物的给药方案。历史上，许多给予儿童的药物的剂量方案都是基于在成年人中生成的药代动力学数据。“成人”剂量只是根据儿童的体重或体表面积进行调整。这种做法存在潜在的安全风险，药物监管机构无法接受。在儿童中获取药代动力学数据存在伦理问题和技术挑战，因为药代动力学研究需要反复测量血液中的药物水平。结合群体药代动力学建模技术使用干血斑（DBS）样本是在儿童中进行药代动力学研究的一种潜在方法。在本文中，我们回顾了 DBS 技术在进行药代动力学研究中的应用，并强调了仍需要解决的问题，以确立 DBS 作为在儿童中进行药代动力学研究的方法。
