Verhaeghe Tom, Dillen Lieve, Stieltjes Hans, Zwart Loeckie de, Feyen Bianca
Development Bioanalysis, Janssen Research & Development, A Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.
Drug Metabolism & Pharmacokinetics, Janssen Research & Development, A Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.
Bioanalysis. 2019 Jun;11(13):1233-1242. doi: 10.4155/bio-2019-0085. Epub 2019 Jul 12.
Following the request of a regulatory authority, a rat study was conducted to compare pharmacokinetic parameters from traditional large volume sampling and capillary microsampling. Rats were dosed with a proprietary compound in three dose groups and blood samples were collected via capillary microsampling (32 μl), immediately followed by traditional large volume sampling (300 μl) up to 24 h postdose. Resulting plasma samples were analyzed for parent drug and two metabolites. AUCs were compared between sampling techniques. There was no statistical difference between AUCs from traditional and microsampling across different doses and analytes. Toxicokinetic parameters generated from plasma collected as a capillary microsample or traditional large volume sample are highly comparable.
应监管机构要求,开展了一项大鼠研究,以比较传统大容量采样和毛细管微量采样的药代动力学参数。将大鼠分为三个剂量组,给予一种专利化合物,通过毛细管微量采样(32 μl)采集血样,随后立即进行传统大容量采样(300 μl),直至给药后24小时。对所得血浆样本分析母体药物和两种代谢物。比较了不同采样技术之间的AUC。不同剂量和分析物的传统采样和微量采样的AUC之间无统计学差异。由毛细管微量样本或传统大容量样本采集的血浆生成的毒代动力学参数具有高度可比性。