治疗药物监测技术质量保证的发展状况

摘要

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.%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。