GLP条件下供试品管理的探讨

Investigation on Management of Test Article in Compliance with GLP

供试品的有效管理是保证非临床安全性评价结果可靠性的关键因素。本文从供试品的管理人员要求、接收、保存、留样、分发领用、剩余供试品的处理、配制及配制物的检测分析等方面提出了管理方法和注意事项。

The effective management of test article is central to the validity of the nonclinical safety evaluation. This article comprehensively introduces management technique and announcement of test article in respect of qualification of administrator, receipt, storage, sample reservation, distribution, disposition of excess test article, preparation, analysis of formulation.