高变异药物生物等效性研究的样本全生命周期模式质量管理的探讨

Full-life-cycle sample quality management of highly variable drug bioequivalence trials

高变异药物的临床试验研究因受试者数量的增加或采用重复交叉设计,导致生物样本的数量较大,对于样本的管理提出了更严格的要求。本文分析和介绍了高变异药物生物等效性研究样本的全生命周期管理的关键点和详尽的工作策略及工作模式的建立,探讨从质量管理角度剖析涉及到样本管理整个过程的各个环节,把控样本管理的全生命周期,从而更加科学可靠地做好高变异药物的临床试验研究,希望有助于临床研究单位对高变异药物临床试验样本管理问题的重视和高变异药物生物等效性研究质量的提高。

Due to the increase of the number of subjects or the use of repeated crossover design,the number of biological samples in the clinical trials of highly variable drug is large,and the management of samples is more stringent.This paper introduces the highly variable drug analysis and drug bioequivalence research sample the full-life-cycle management of the key strategy and detailed work and the establishment of the working mode,discussed from the perspective of quality management sample analysis involves the whole process management of each link,the full-life-cycle of the control sample management,and a more scientific and reliable to do the highly variable drug clinical trials,wants to help clinical research unit of highly variable drug clinical trials sample management attention and highly variable drug bioequivalence research quality.