Comparison of toxicokinetic parameters of a drug and two metabolites following traditional and capillary microsampling in rat.

• 影响指数: 2.695
• 发表时间: Jun 2019
• 来源期刊: Bioanalysis
• DOI: 10.4155/bio-2019-0085
• PMID: 31298569
• 文章类型: Comparative Study
• 中科院分区: Q2;Q2
• 作者列表: Verhaeghe T,Dillen L,Stieltjes H,Zwart L,Feyen B

关键词: AUC; GLP; NC3Rs; assay validation; bridging study; capillary microsampling; end-to-end capillaries; rat studies; toxicokinetics; toxicology

Mesh: Animals; Area Under Curve; Blood Specimen Collection / methods standards; Capillaries; Chromatography, High Pressure Liquid; Dried Blood Spot Testing; Half-Life; Male; Pharmaceutical Preparations / blood chemistry metabolism; ROC Curve; Rats; Rats, Sprague-Dawley; Tandem Mass Spectrometry

Abstract

Aim: Following the request of a regulatory authority, a rat study was conducted to compare pharmacokinetic parameters from traditional large volume sampling and capillary microsampling. Materials & methods: 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. Results: There was no statistical difference between AUCs from traditional and microsampling across different doses and analytes. Conclusion: Toxicokinetic parameters generated from plasma collected as a capillary microsample or traditional large volume sample are highly comparable.