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试验用药品(IP),是指用于临床试验中的试验药物,对照药品或安慰剂[1]。试验用药品的管理是《药物临床试验质量管理规范》GCP实施过程中的重要内容,是药品注册现场核查和药物临床试验机构资格认定与复核检查的一个重点关注环节。药物临床试验中,试验用药品的使用记录应包括数量、装运、递送、接收、分配、应用后剩余药物的回收与销毁等方面的信息。为加强试验用药品的管理,规范药物临床试验机构在临
Test drug (IP) refers to the test drug used in clinical trials, control drugs or placebo [1]. The management of experimental drugs is an important part of the GCP implementation process of the “Code of Practice for Quality Control of Pharmaceutical Clinical Trials”, and is a key link in the field of drug registration verification and accreditation and review of drug clinical trial institutions. In drug clinical trials, records of the use of test drugs should include information on quantity, shipment, delivery, receipt, distribution, and recovery and destruction of remaining drugs after application. In order to strengthen the management of experimental drugs, standard drug clinical trial institutions are on their way