Wang Jin, Burns Daniel, Ma Mark
Pharmacokinetics & Drug Metabolism Department, Amgen Inc., Thousand Oaks, CA 91320, USA.
Bioanalysis. 2012 Feb;4(4):359-65. doi: 10.4155/bio.11.324.
During nonclinical regulated toxicology studies, blood processing protocol deviations may negatively impact sample integrity and bioanalytical results. Standard practices for resolution of blood processing issues are not well established across the industry. In this article, using an illustrative example, we present a systematic approach to investigate and assess the impact of nonclinical blood processing protocol deviations that involve: assessment of the potential impact of deviations on toxicokinetic evaluation, performance of additional blood processing stability tests to ensure study sample integrity and establishment of study sample results reporting procedures to meet both scientific and regulatory quality requirements. This thorough and systematic approach can serve as a model for other analogous situations.
在非临床规范毒理学研究中，血液处理方案的偏差可能会对样品完整性和生物分析结果产生负面影响。整个行业尚未很好地确立解决血液处理问题的标准做法。在本文中，我们通过一个示例，提出一种系统方法来调查和评估非临床血液处理方案偏差的影响，该方法包括：评估偏差对毒代动力学评估的潜在影响、进行额外的血液处理稳定性测试以确保研究样品的完整性，以及建立研究样品结果报告程序以满足科学和监管质量要求。这种全面且系统的方法可作为其他类似情况的范例。
