Cheymol G
Ann Med Interne (Paris). 1987;138(3):173-7.
Clinical trials without immediate therapeutic objectives are performed in phases I and III of drug testing. In phase I, the studies in a small number of healthy volunteers provide information about tolerance, dosage, pharmacokinetics and often, about the principal effects. In phase III, the therapeutic value of the drug has been demonstrated, and the aims are to determine the circumstances which increase the risk of iatrogenicity. These trial are carried out in elderly patients and in those with hepatic or renal failure. In addition, information about drug interactions may be required for the AMM report. Examples are given to illustrate these principles. The author recall the conditions which must be strictly adhered to in the execution of these trials.
没有直接治疗目标的临床试验在药物测试的I期和III期进行。在I期，对少数健康志愿者进行的研究提供了关于耐受性、剂量、药代动力学的信息，并且通常还提供了关于主要效应的信息。在III期，药物的治疗价值已经得到证实，目的是确定增加医源性风险的情况。这些试验在老年患者以及肝或肾功能衰竭患者中进行。此外，AMM报告可能需要有关药物相互作用的信息。给出了例子来说明这些原则。作者回顾了在进行这些试验时必须严格遵守的条件。
