隨著動(dòng)物福利指導(dǎo)原則的提出, 大量替代方法逐步應(yīng)用于藥物非臨床安全性評(píng)價(jià)領(lǐng)域。然而, 我國在藥物非臨床研究質(zhì)量管理規(guī)范(GLP)中, 體外替代技術(shù)的發(fā)展仍處于起步階段。從人員、實(shí)驗(yàn)設(shè)施、標(biāo)準(zhǔn)操作規(guī)程、質(zhì)量保證體系、電子數(shù)據(jù)管理等方面, 闡述在GLP體系下如何規(guī)范替代方法, 嚴(yán)格控制可能影響實(shí)驗(yàn)結(jié)果準(zhǔn)確性的各種主客觀因素, 降低實(shí)驗(yàn)誤差, 確保實(shí)驗(yàn)結(jié)果的真實(shí)性, 以推動(dòng)替代技術(shù)在藥物非臨床安全性評(píng)價(jià)中的應(yīng)用。

As Animal Welfare Guideline proposed, a large number of alternative methods have been applied in the non-clinical areas of drug safety evaluation. This paper describes the formation and the status quo of alternative techniques in vitro in China's non-clinical studies on drug law quality management standards from the views on staff, experimental facilities, standard operating procedures, quality assurance system, electronic data management. Under the GLP system, how to regulate the alternative methods and to strict the control of various subjective and objective factors that may affect the accuracy of the results, reduce experimental error, ensure the authenticity of the results are elaborated in order to promote tehe alternative techniques in non-clinical applications in drug safety evaluation.