With increasing numbers of drugs tested in oncology for smaller patient populations, fewer patients are available to answer important clinical pharmacological questions in the timeframe of clinical drug development. The quality and efficiency of trials to assess the pharmacokinetics of new drugs can be improved by making better use of available resources. One approach to do this is by making more effective use of isotopic tracer techniques. With increasing sensitivity of liquid chromatography-tandem mass spectrometry analyzing equipment over the years, it has now become possible to generate much more rich, high-quality pharmacokinetic data than before. In particular we want to make a plea here for a hybrid trial approach, where both radiolabeled drug and stable isotopically labeled drug are administered to patients to assess both the absolute bioavailability and absorption, distribution, metabolism and excretion in a single clinical trial experiment.

随着针对较小患者群体的肿瘤学测试药物数量的增加，在临床药物开发的时间范围内，越来越少的患者可以回答重要的临床药理问题。通过更好地利用可用资源，可以提高评估新药药代动力学的试验的质量和效率。一种方法是更有效地利用同位素示踪技术。多年来，随着液相色谱-串联质谱分析设备灵敏度的提高，与以前相比，现在已经可以生成更加丰富，高质量的药代动力学数据。特别是，我们希望在这里提出一种混合试用方法，