非临床安全性评价中离乳前给药的幼龄动物分组设计

Design on grouping of juvenile animal dosed prior to weaning during non-clinical safety evaluation

依据儿童年龄的划分,幼龄动物非临床研究的初次给药可能会在离乳前。因此,给药设计是以窝为背景进行的。对于啮齿类动物生理和行为的变化,窝的影响最大,随着动物年龄的变化更是如此。幼龄动物非临床研究设计中也必须考虑到窝的影响。幼龄动物非临床研究中窝的构成主要有:1窝内设计。2窝间设计。3单只幼仔/性别/窝。4抚育设计。本文结合本实验室的经验针对各种分组设计的优缺点、关键点包括操作程序和孕鼠数量等展开论述。

Depending upon the pediatric age classification,juvenile toxicity studies often initiate dosing prior to weaning. Therefore,dosing must be performed in the litter setting. The litter is the largest contributor to physical and behavioral variability in rodents and actually becomes more so as animals age. Juvenile non-clinical research design must also consider the influence of the litter. There are several methods of litter composition：1 within litter design; 2 between litter design; 3 one pup per sex per litter design; 4 fostering design. In this paper,combined with the experience of our laboratory,the advantages and disadvantages of the experimental grouping,and key points including operating procedures and number of pregnant rats were discussed.