药物临床试验用药品全流程管理分析探讨

Analysis and Discussion on the Whole Process Management of Drugs Used in Drug Clinical Trials

药品临床试验是药物获准上市前所必须要进行的前期环节,这一环节的结果直接影响到药物上市的流程和进度,作为尚未达到上市标准的药物,其在临床试验阶段的全流程管理具有着重要的安全价值。本文旨在探讨分析药物临床试验用药品的全流程管理,从国内外药物临床试验用药品的相关法规分析其全流程中的问题,并对临床试验用药的生产、运输、使用、管理和安全性等各个流程的具体内容进行探讨分析。基于对临床试验用药全过程分析,提出有助于增强药品质量、效率、保障受试者权益的重要对策和方向,从而有效提升试验用药品的管理水平提供建立坚实的基础,有效推动临床试验用药品的规范化管理。

Drug clinical trials are the preliminary links that must be carried out before the drug is approved for marketing.The results of this link directly affect the process and progress of drug marketing.As a drug that has not yet reached the marketing standard,its whole process management in the clinical trial stage has important safety value.The purpose of this paper is to explore and analyze the whole process management of drugs for clinical trials,analyze the problems in the whole process from the relevant laws and regulations of drugs for clinical trials at home and abroad,and discuss and analyze the specific contents of the production,transportation,use,management and safety of clinical trial drugs.Based on the analysis of the whole process of clinical trial medication,this paper puts forward important countermeasures and directions to help enhance the quality and efficiency of drugs and protect the rights and interests of subjects,so as to effectively improve the management level of experimental drugs,provide a solid foundation,and effectively promote the standardized management of clinical trial drugs.