急性毒性试验的研究进展_王庆利.pdfVIP

Chinese Journal ofN ew Drugs 2009, 18( 21) # # , , ( 国家食品药品监督管理局药品审评中心, 北京 100038) [] ICH 及其指导原则M3中对急性毒性试验的科学 义在药物研发进程中的时间安排注册要 求等进行了大量讨论近几年, 随着制药企业间药物非临床研究资料的共享, 以及动物试验 3R 原则的不断 推进, 急性毒性试验在药物研发及注册中的作用正发生着深刻的变化文中结合我国新药研发和指导原则 的实际情况, 对该试验的研究进展及科学背景进行讨论, 为我国的研究和管理要求提供 一些参考 [] 急性毒性试验; 单次给药毒性试验; 半数致死量( LD ) 50 [] R965. 3 [] A [] 1003 3734( 2009) 2024 04 Advance in studies of acute drug toxicity WANG Qing li, WANG Haixue, MA Lei (Centerf orD rug Evaluation, StateFood and Drug Administration, Beij ing 100038, China) [Abstract] Traditionally, single dose toxicity studies in anmi als, programmed in early phase of new drug development, are usually required for any pharmaceuticals intended for human use. International conference on harmonization of technical requirem ents for registration of pharmaceuticals for human use ( ICH ) and the guideline M3 discussed the scientific background of the study, and recommended the development strategies and requirements for registration. In recent years, w ith the share of nonclinical safety studies conducted bewt een companies and the consideration of the 3Rs principles, suggestions in refining the single dose toxicity study were presented. [Key words] acute toxicity; single dose toxicity; LD50 , 3R ( refinem ent, reduction, replacement) ( acute toxicity study, single dose , SDT toxicity study, SDT), , , ICH M3 SDT SDT ( ICH ) , SDT (M3) SDT 1 SDT 2005 1991 ICH , ( SFDA), ( OECD) SDT , ICH