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临床研究中的毛细血管微采样:两个案例研究中的机遇与挑战。

Capillary microsampling in clinical studies: opportunities and challenges in two case studies.

机构信息

Development Bioanalysis, Janssen Research & Development, A division of Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium.

出版信息

Bioanalysis. 2020 Jul;12(13):905-918. doi: 10.4155/bio-2020-0054. Epub 2020 Jul 6.

Abstract

Capillary microsampling of 15 μl whole blood from fingersticks or heelsticks was used to collect pharmacokinetic (PK) samples from pediatric subjects in two projects. In a mebendazole multisite study in Ethiopia and Rwanda in subjects between 1 and 16 years old, complete PK profiles (7 timepoints) could be obtained, although some of the fingerstick samples were contaminated by the dosing formulation. In a multisite study with a respiratory syncytial virus drug in children between 1 and 24 months old, sparse PK sampling was done (2 samples). All samples were successfully analyzed even though some capillaries were not properly filled. CMS shows potential for PK sampling in pediatrics but may need further optimization.

摘要

采用毛细管微量采血量 15μl 的指血或足跟血,从年龄在 1 至 16 岁的儿科受试者中采集药代动力学(PK)样本,用于 2 个项目。在埃塞俄比亚和卢旺达开展的甲苯咪唑多中心研究中,尽管部分指血样本受到用药制剂的污染,但仍可获得完整的 PK 谱(7 个时间点)。在针对 1 至 24 月龄儿童的呼吸道合胞病毒药物多中心研究中,仅进行稀疏 PK 采样(2 个样本)。即使有些毛细管未完全充满,所有样本也都成功进行了分析。CMS 显示出在儿科进行 PK 采样的潜力,但可能需要进一步优化。

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