【摘要】 介绍美国上市的治疗性单克隆抗体药物说明书中有关临床检验的相关内容,以期对我国说明书的撰写和监管有所启迪。以美国FDA收录的治疗性单抗说明书为研究对象,检索其中与临床检验相关的内容。截止2016年5月30日,FDA已批准并在售的共有47种治疗性单抗。在这些药物的说明书中,均提供了与临床检验相关的信息,主要包括治疗前患者筛选所需完成的临床检验、疗效及副反应所需的临床检验以及部分药物对临床检验的干扰等3个方面的内容。美国FDA治疗性单抗说明书中均明确临床检验的相关内容,是研究药物与检验的重要信息来源。药品生产企业及药品监督部门需规范及完善药品说明书内容,为临床用药提供更多的帮助。更多还原

【Abstract】 This paper presents the information of clinical laboratory tests in US therapeutic monoclonal antibodies’ labels and offers some enlightenment for the drug labeling development and administration in China. The labels for therapeutic monoclonal antibodies were searched and reviewed manually for their information related to the clinical laboratory tests. There are 47 therapeutic monoclonal antibodies approved by FDA and available in US market for clinical usage up to May 30 th,2016. The labels provide the information of clinical laboratory tests,including patients screening,adverse reaction monitoring and drug impairing laboratory tests. Prescription drug label is an excellent information resource for the study of clinical laboratory tests in drug usage. For the government regulatory agency and the drugs manufactures,standardization of the drug labels is necessary to provide more useful information to the patients and medical professional staff.更多还原