Spooner Neil, Anderson Kenneth D, Siple Joe, Wickremsinhe Enaksha R, Xu Yang, Lee Mike
Spooner Bioanalytical Solutions Ltd, Hertford, UK & School of Life & Medical Sciences University of Hertfordshire, UK.
Merck & Co. Inc., Department of Pharmacokinetics, Pharmacodynamics & Drug Metabolism, West Point, PA 19486, USA.
Bioanalysis. 2019 May;11(10):1015-1038. doi: 10.4155/bio-2019-0041.
There is growing interest in the implementation of microsampling approaches for the quantitation of circulating concentrations of analytes in biological samples derived from nonclinical and clinical studies involved in drug development. This interest is partly due to the ethical advantages of taking smaller blood volumes, particularly for studies in rodents, children and the critically ill. In addition, these technologies facilitate sampling to be performed in previously intractable locations and occasions. Further, they enable the collection of samples for additional purposes (extra time points, biomarkers, sampling during a clinical event, etc). This article gives a comprehensive insight to the utilization of these approaches in drug discovery and development, and provides recommendations for best practice for nonclinical, clinical and bioanalytical aspects.
对于在药物开发所涉及的非临床和临床研究中获得的生物样品，采用微量采样方法来定量分析物的循环浓度，人们的兴趣日益浓厚。这种兴趣部分源于采集较小血量在伦理方面的优势，特别是对于啮齿动物、儿童和重症患者的研究。此外，这些技术便于在以前难以进行采样的地点和场合进行采样。而且，它们能够为其他目的（额外的时间点、生物标志物、临床事件期间的采样等）收集样品。本文全面深入地探讨了这些方法在药物发现和开发中的应用，并为非临床、临床和生物分析方面的最佳实践提供了建议。
