隨著醫(yī)藥研發(fā)的全球化發(fā)展,國(guó)內(nèi)新藥安全評(píng)價(jià)機(jī)構(gòu)獲得藥物非臨床研究質(zhì)量管理規(guī)范（GLP）和國(guó)際實(shí)驗(yàn)動(dòng)物評(píng)估和認(rèn)可管理委員會(huì)（AAALACi）雙認(rèn)證的越來越多。實(shí)驗(yàn)動(dòng)物作為藥物安全性評(píng)價(jià)的載體,其生存狀態(tài)和動(dòng)物福利將直接影響到試驗(yàn)結(jié)果,處理好兩種體系下實(shí)驗(yàn)動(dòng)物的飼養(yǎng)管理工作,是保證實(shí)驗(yàn)數(shù)據(jù)準(zhǔn)確的必要條件。以天津藥物研究院新藥評(píng)價(jià)有限公司通過GLP和AAALACi兩種體系認(rèn)證的實(shí)際工作經(jīng)驗(yàn)為基礎(chǔ),輔以與同行們的交流經(jīng)驗(yàn),探討兩種認(rèn)證體系在實(shí)驗(yàn)動(dòng)物管理工作中的關(guān)系,以期通過加強(qiáng)實(shí)驗(yàn)動(dòng)物管理工作來保障新藥安全評(píng)價(jià)工作的順利進(jìn)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.