通过GLP和AAALACi认证的新药安全评价实验动物管理

Management of laboratory animals of new drug safety evaluation in GLP and AAALACi certification systems

随着医药研发的全球化发展,国内新药安全评价机构获得药物非临床研究质量管理规范(GLP)和国际实验动物评估和认可管理委员会(AAALACi)双认证的越来越多。实验动物作为药物安全性评价的载体,其生存状态和动物福利将直接影响到试验结果,处理好两种体系下实验动物的饲养管理工作,是保证实验数据准确的必要条件。以天津药物研究院新药评价有限公司通过GLP和AAALACi两种体系认证的实际工作经验为基础,辅以与同行们的交流经验,探讨两种认证体系在实验动物管理工作中的关系,以期通过加强实验动物管理工作来保障新药安全评价工作的顺利进行。

With the global development of the research of medicine,more and more new drug safety evaluation institutions have been certified by Good Laboratory Practices （GLP） and Association for Assessment and Accreditation of Laboratory Animal Care International （AAALACi）.Laboratory animal,which is the carrier of drug safety evaluation,its survival condition and animal welfare will directly effect the experimental results.Dealing with laboratory animal husbandry by scientific methods in two systems is the requirement to make sure the accuracy of experimental data of animal experiments.With the certification processes and practical experiences in two certification systems of Tianjin Institute of Pharmaceutical Research New Drug Evaluation Co.,Ltd.,also accompanied by experience exchangement with peers,the relationship of practices in two certification systems will be preliminarily discussed;Through strengthening the management of laboratory animal,it can help the institutions get the certificates.