Richens A
Ciba Found Symp. 1979(74):69-79. doi: 10.1002/9780470720578.ch5.
Most routine drug assay work is done by clinical chemists who, in general, are well aware of the importance of regular quality control checks. Few, however, have had extensive experience in analytical techniques for drugs, such as gas chromatography, and often underrate the difficulty in obtaining reliable results. Although antiepileptic drugs are among the easiest to measure, a North American study organized by Dr Charles Pippenger and a European study performed by the author demonstrated clearly the poor quality of results coming from many laboratories. From these studies have grown two external quality control schemes which together involve over 800 laboratories on a world-wide basis. Reports have indicated that the reliability of theophylline, tricyclic antidepressant and phenothiazine assays is also poor, and it might be expected that the problems will increase as attempts are made to measure drugs present in lower concentrations. Careful attention to quality control will be essential if physicians are to be provided with reliable results.
大多数常规药物检测工作由临床化学家完成，他们总体上很清楚定期进行质量控制检查的重要性。然而，很少有人在药物分析技术方面有丰富经验，比如气相色谱法，而且他们常常低估获得可靠结果的难度。尽管抗癫痫药物是最容易测定的药物之一，但查尔斯·皮彭杰博士组织的一项北美研究以及作者进行的一项欧洲研究清楚地表明，许多实验室得出的结果质量很差。基于这些研究，已经形成了两项外部质量控制计划，全球共有800多个实验室参与其中。报告指出，茶碱、三环类抗抑郁药和吩噻嗪检测的可靠性也很差，而且可以预计，随着人们试图测定更低浓度的药物，问题将会增加。如果要为医生提供可靠的结果，那么认真关注质量控制至关重要。
