[關(guān)鍵詞]
[摘要]
國(guó)際實(shí)驗(yàn)動(dòng)物評(píng)估與認(rèn)證是實(shí)驗(yàn)動(dòng)物管理和科學(xué)應(yīng)用高標(biāo)準(zhǔn)的象征,是國(guó)際認(rèn)可的質(zhì)量標(biāo)準(zhǔn)。介紹國(guó)際實(shí)驗(yàn)動(dòng)物評(píng)估與認(rèn)證的基本概念、方法、步驟及注意事項(xiàng)等,特別是實(shí)驗(yàn)動(dòng)物管理與使用委員會(huì)(IACUC)、獸醫(yī)和職業(yè)安全與健康(OHS)在認(rèn)證中的重要作用,闡述開(kāi)展國(guó)際實(shí)驗(yàn)動(dòng)物評(píng)估與認(rèn)證對(duì)新藥研發(fā)公司及研究機(jī)構(gòu)在提高藥品非臨床安全性研究的質(zhì)量與國(guó)際認(rèn)可度,確保實(shí)驗(yàn)方案合理以及實(shí)驗(yàn)結(jié)果的可靠有效等方面的意義,為國(guó)內(nèi)相關(guān)機(jī)構(gòu)開(kāi)展國(guó)際實(shí)驗(yàn)動(dòng)物評(píng)估與認(rèn)證起到拋磚引玉的作用。
[Key word]
[Abstract]
Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation is the symbol of high standards for animal care and use, and is the landmark of a world-wide acceptable high quality of medicinal research. In this paper, the basic concept and procedure of AAALAC accreditation as well as some special issues are introduced, the important role of Institutional Animal Care and Use Committee (IACUC), veterinarian, and occupational health and safety (OHS) to play in AAALAC accreditation is clarified, the significance of AAALAC accreditation in improvement of pre-clinical safety evaluation of an investigational drug is described with ensuring the reliability, validity, repeatability, and international recognition of the experiments and their results. It is very imperative for GLP laboratories in domestic institutions to get AAALAC accreditation.
[中圖分類(lèi)號(hào)]
[基金項(xiàng)目]
基金項(xiàng)目:“重大新藥創(chuàng)制”科技重大專(zhuān)項(xiàng)(Z20082X09305-005);天津創(chuàng)新藥物安全評(píng)價(jià)技術(shù)平臺(tái)建設(shè)