隨著醫(yī)藥研發(fā)的全球化發(fā)展,國內新藥安全評價機構獲得藥物非臨床研究質量管理規(guī)范（GLP）和國際實驗動物評估和認可管理委員會（AAALACi）雙認證的越來越多。實驗動物作為藥物安全性評價的載體,其生存狀態(tài)和動物福利將直接影響到試驗結果,處理好兩種體系下實驗動物的飼養(yǎng)管理工作,是保證實驗數據準確的必要條件。以天津藥物研究院新藥評價有限公司通過GLP和AAALACi兩種體系認證的實際工作經驗為基礎,輔以與同行們的交流經驗,探討兩種認證體系在實驗動物管理工作中的關系,以期通過加強實驗動物管理工作來保障新藥安全評價工作的順利進行。

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.