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Novel methodology to perform incurred sample reanalysis on dried blood spot cards: Experimental data using darolutamide and filgotinib.
Biomedical Chromatography ( IF 1.8 ) Pub Date : 2020-07-02 , DOI: 10.1002/bmc.4938
Vinay Kiran 1 , Abhishek Dixit 1 , Bhavesh Babulal Gabani 1 , Nuggehally R Srinivas 2 , Ramesh Mullangi 1
Affiliation  

Different options on performing incurred sample reanalysis (ISR) on dried blood spot (DBS) cards were investigated using drugs belonging to various therapeutic areas: (a) darolutamide (to treat prostate cancer) and (b) filgotinib (to treat rheumatoid arthritis). The proposed novel methodology included the generation of half‐DBS and quarter‐DBS discs after initial blood collection using the full‐DBS discs. Accordingly, blood collection via DBS was performed in male BALB/c mice following intravenous and oral dosing of darolutamide; in male Sprague Dawley rats following intravenous and oral dosing of filgotinib. The ISR data generated from the full‐DBS disc, half‐DBS disc and quarter‐DBS disc were compared for the assessment of the proposed methodology. Quantification of darolutamide and filgotinib was accomplished using liquid chromatography‐electrospray ionization/tandem mass spectrometry methods. Darolutamide and filgotinib ISR samples, which were collected and prepared using full‐, half‐ and quarter‐DBS discs, met the acceptance criteria for ISR analysis. In conclusion, this is the first report showing a viable tool for the performance of ISR on DBS cards. The use of quarter‐ or half‐DBS discs would aid in not only ISR but also in long‐term storage experiments of analytes because it would avoid the need for additional blood sampling in patients.

中文翻译:

在干血斑卡上进行样本再分析的新方法:使用达洛鲁胺和非洛替尼的实验数据。

使用属于各个治疗领域的药物研究了在干血斑(DBS)卡上进行样本再分析(ISR)的不同选项:(a)达洛鲁胺(用于治疗前列腺癌)和(b)filgotinib(用于治疗类风湿性关节炎)。提议的新颖方法包括使用全DBS光盘进行初次采血后生成半DBS和四分之一DBS光盘。因此,在静脉注射和口服达洛鲁胺后,在雄性BALB / c小鼠中通过DBS进行了采血。filgotinib静脉内和口服给药后,在雄性Sprague Dawley大鼠中的作用。比较了从完整DBS光盘,半DBS光盘和四分之一DBS光盘生成的ISR数据,以评估所提出的方法。使用液相色谱-电喷雾电离/串联质谱法对达洛鲁胺和非洛替尼进行定量。使用全,半和四分之一DBS光盘收集和制备的达洛鲁胺和非戈替尼ISR样品符合ISR分析的可接受标准。总之,这是第一份报告,显示了在DBS卡上执行ISR的可行工具。使用四分之一或一半的DBS光盘不仅有助于ISR,而且还有助于分析物的长期存储实验,因为这样可以避免对患者进行额外的血液采样。这是第一份报告,显示了在DBS卡上执行ISR的可行工具。使用四分之一或一半的DBS光盘不仅有助于ISR,而且还有助于分析物的长期存储实验,因为这样可以避免对患者进行额外的血液采样。这是第一份报告,显示了在DBS卡上执行ISR的可行工具。使用四分之一或一半的DBS光盘不仅有助于ISR,而且还有助于分析物的长期存储实验,因为这样可以避免对患者进行额外的血液采样。
更新日期:2020-07-02
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