Johnson Victor J, Luster Michael I, Maier Andrew, Boles Corey, Miller Eric W, Arrieta Daniel E
Burleson Research Technologies, Inc., Morrisville, NC, United States.
Luster Assoc. LLC, Morgantown, WV, United States.
Front Toxicol. 2024 Oct 4;6:1409365. doi: 10.3389/ftox.2024.1409365. eCollection 2024.
The use of immunophenotyping during immunotoxicity investigations was first popularized in the 1980 s and has since become more integrated into diagnostic and non-clinical assessments. The data provided from immunophenotyping can serve as an initial source of information to guide decisions for additional, more advanced, immunotoxicity testing as well as for human health safety and risk assessment of drugs and chemicals. However, comprehensive guidance describing applications of immunophenotyping data in immunotoxicity investigations is lacking, particularly among regulatory bodies. Therefore, a critical examination is needed for the appropriate interpretations and potential misinterpretations of such data during the assessment of drug safety and chemical risk. As such, the current uses and implications of immunophenotyping data in human health safety and risk assessments has been evaluated to provide additional context for the application of current methodologies and guidelines. In addition, case studies are presented to highlight the challenges of interpreting immunophenotyping results along with incorporating the findings into immunotoxicity investigations. Based on the analyses of current approaches and methodologies, a decision flow is presented for use of immunophenotyping data during risk informed decision making.
免疫表型分析在免疫毒性研究中的应用于20世纪80年代首次得到推广，此后已更多地融入诊断和非临床评估中。免疫表型分析提供的数据可作为初始信息来源，用于指导开展更多、更先进的免疫毒性测试，以及进行药物和化学品的人体健康安全性及风险评估。然而，目前缺乏全面指导，说明免疫表型分析数据在免疫毒性研究中的应用，监管机构尤其如此。因此，在评估药物安全性和化学风险时，需要对这类数据的恰当解读和潜在误读进行批判性审视。为此，已对免疫表型分析数据在人体健康安全性及风险评估中的当前用途和影响进行了评估，以便为当前方法和指南的应用提供更多背景信息。此外，还介绍了案例研究，以突出解读免疫表型分析结果以及将研究结果纳入免疫毒性研究的挑战。基于对当前方法和技术的分析，给出了一个决策流程，用于在基于风险的决策过程中使用免疫表型分析数据。
