摘要
本文综述治疗药物监测(TDM)实施的三个阶段,即分析前、分析中和分析后的主要技术质量要求。在分析前阶段,需要在特定的时间窗采集而获得有效的生物样本;在分析阶段,分析方法要经过确证,还需评估可能的干扰物质;在分析后阶段,目标是最终的TDM报告,应包括正确的结果解释以及有益的建议。
The article reviews the technique and quality assurance of therapeutic drug monitoring （TDM） in pre-analytical, analytical and post-analytical phases. In the pre-analytical phase, it is necessary to acquire a valid specimen collected at the specific time window. In the analytical phase, the analytical methods should be validated, assessing possible interfering substances is also necessary. The objective of the post-analytical phase is the final report, which should include correct interpretation as well as possible advice.
出处
《药学与临床研究》
2014年第5期427-432,共6页
Pharmaceutical and Clinical Research
基金
江苏省第七批"六大人才高峰"资助项目(2010WSN-204)
关键词
治疗药物监测
分析前阶段
分析中阶段
分析后阶段
技术
质量保证
Therapeutic drug monitoring
Pre-analytical phase
Analytical phase
Post-analytical phase
Technique
Quality assurance
