第一个针对口服球药的国际质量控制计划的结果
Eline L Giraud1, Lindsey M H Te Brake1, Erik C A van den Hombergh1
1Department of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Centre, Nijmegen, The Netherlands.
British journal of clinical pharmacology
|September 30, 2023
概括
这项质量控制计划发现,80.7%的实验室测量对口服瘤治疗向药物是准确的. 这确保了可靠的治疗药物监测 (TDM) 以更好的癌症治疗剂量.
科学领域:
- 在瘤学瘤学.
- 分析化学 分析化学
- 临床药理学 临床药理学
背景情况:
- 越来越多地使用口服向性瘤治疗药物,需要可靠的治疗药物监测 (TDM).
- 试验验证对于准确的药物度测量至关重要,影响癌症治疗中的剂量决定.
研究的目的:
- 评估实验室在量化口服向性瘤学度方面的表现.
- 评估这些药物的国际质量控制 (QC) 计划中的测量质量.
主要方法:
- 来自6个国家的17个实验室参加了一次性国际质量控制计划.
- 分析了具有不同度的九种口服向瘤学药物的血样本.
- 准确性被定义为在参考度的85%-115%内的测量;使用ANOVA进行分析.
主要成果:
- 总体而言,在报告的243个测量中,80.7%的测量符合准确性标准.
- 实验室的性能各不相同,伊马替尼布的准确度最高,而代乙苏尼提尼布的准确度最低.
- 药物物质和实验室等因素影响了测量不准确性.
结论:
- 该研究表明,口服向性瘤学药物的第一个国际QC计划中,准确测量的百分比很高.
- 试验的交叉验证对于可靠的剂量优化和患者安全至关重要.
- 确保测定性能可以保护患者免受潜在的错误治疗建议.
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