Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA.
Pfizer Inc., 10555 Science Center Dr, San Diego, CA 92121, USA.
Bioanalysis. 2024;16(15):825-834. doi: 10.1080/17576180.2024.2388939. Epub 2024 Sep 5.
The feasibility of using Tasso devices (Tasso-SST and Tasso) collecting capillary blood samples for measuring abrocitinib and its metabolites were evaluated, and assay concordance established between capillary and venous blood samplings. Capillary serum and venous plasma concentrations were measured using their respective qualified and validated assays. Concentration and exposure comparisons were conducted for abrocitinib and its metabolites (M1, M2 and M4) to establish assay concordance. The correlation coefficient between capillary serum and venous plasma concentrations were >0.98 for all four analytes from three separate assays, and PK parameters (AUC and C) were compared and met bioequivalence criteria. These results demonstrate the feasibility of patient-centric microsampling device, such as Tasso, in future abrocitinib pediatric study.
评估了 Tasso 设备（Tasso-SST 和 Tasso）采集毛细血管血样测量阿布昔替尼及其代谢物的可行性，并建立了毛细血管血样和静脉血样之间的分析方法一致性。使用各自的合格和验证的分析方法测量毛细血管血清和静脉血浆浓度。比较阿布昔替尼及其代谢物（M1、M2 和 M4）的浓度和暴露量，以建立分析方法一致性。来自三个独立分析的所有四个分析物的毛细血管血清和静脉血浆浓度之间的相关系数均>0.98，并且 PK 参数（AUC 和 C）进行了比较并符合生物等效性标准。这些结果表明，在未来的阿布昔替尼儿科研究中，以患者为中心的微采样装置，如 Tasso，是可行的。
