Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)
Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)
复制标题
DOI：
10.1128/aac.02362-14
复制
发表时间：
2014-07-01
影响因子：
4.9
通讯作者：
Tarning, Joel
中科院分区：
文献类型：
--
作者：
Lourens, Chris;Lindegardh, Niklas;Tarning, Joel
抗疟药物耐药性的全面评估应包括在临床试验和治疗失败的个人评估中测量抗疟药物的血液或血浆浓度，以便区分真正的耐药性和药物暴露不足。药物计量学建模是必要的，以评估不同人群中的药代动力学-药效学关系，以优化给药。为了有效地实现这两个目标并允许比较来自不同实验室的数据，药物浓度测量的准确性至关重要。实验室程序的能力测试（PT）对于验证测定结果是必要的。在全球抗疟药耐药性网络（WWARN）内，质量保证/质量控制（QA/QC）计划的目标是促进和维持高质量的抗疟检测。质量保证/质量控制计划包括药理学实验室的国际PT计划和提供实验室用抗疟药物标准品、代谢物和内标物的参考物质（RM）计划。RM计划目前将精确称量的抗疟药物标准品、代谢物和内标物分发给44个药理学、体外和药物质量检测实验室。药理学PT项目已将样品送往八个实验室进行四轮测试。WWARN的技术专家为纠正已发现的问题提供了建议，以提高后续分析的性能，并最终提高了数据质量。许多参与者在随后的几轮PT中表现出了实质性的改善。WWARN的QA/QC计划提高了全球实验室抗疟药物测量的质量和价值。这是一个有潜力应用于更广泛地加强实验室和改善其他传染病治疗的模式。
Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases.