新药Ⅰ期临床试验中健康受试者的管理

Administration of volunteer in phase I clinical trials for new drug

Ⅰ期临床试验之目的是研究人体对药物的耐受程度,并通过药物代谢动力学研究,了解药物在人体内的吸收、分布、代谢和消除的规律,为制定给药方案提供依据。Ⅰ期临床试验必须全过程高度重视受试者的安全。因此,加强试验中健康受试者的管理是非常必要的。主要包括受试者的招募、培训、筛选、食宿、用药等环节的管理。

The purpose of phase I clinic trail is to evaluate tolerance of the human body to new drugs and to know its regulations on absorption,distribution,metabolism and elimination in human for supplying the safe dose range and pharmacokinetic properties.Phase I clinic trails must attach great importance to the process of volunteer safety.Thus,it is necessary to strengthen the administration of volunteer in trials,including administration of recruitment,training,screening,room and board,medications,etc.