Korea Institute of Toxicology, Jeongeup, Republic of Korea.
J Med Primatol. 2021 Dec;50(6):281-290. doi: 10.1111/jmp.12546. Epub 2021 Oct 10.
The long-tailed macaque (Macaca fascicularis fascicularis) is an Old World species, which is one among the most commonly used monkeys for pharmaceutical research. However, most of the available background data are not suitable for good laboratory practice (GLP)-regulated drug safety tests because the current reverence value covers fewer indices than necessary. Therefore, in this study, historical data for preclinical safety test were collected and managed.
Twenty-five hematology, 20 clinical chemistry, 19 urine analysis, and 16 organ weights were evaluated in a drug safety test of 228 male and 140 female 2- to 4-year-old long-tailed macaques at the Korea Institute of Toxicology under GLP regulations.
The absolute and relative count of lymphocyte, basophil, and large unstained cell were higher, whereas neutrophil was lower in male than in female monkeys. In serum biochemistry, IP, GGT, ALP, and TCHO of male were higher than female.
Historical data suitable for preclinical safety analysis were determined.
长尾猕猴（Macaca fascicularis fascicularis）是一种旧大陆物种，是用于药物研究的最常用猴子之一。然而，大多数可用的背景数据不适用于符合良好实验室规范（GLP）的药物安全性测试，因为当前的参考值涵盖的指标少于必要指标。因此，在这项研究中，我们收集和管理了临床前安全性测试的历史数据。
在韩国毒理学研究所根据 GLP 规定对 228 只雄性和 140 只 2 至 4 岁的长尾猕猴进行药物安全性测试，评估了 25 项血液学、20 项临床化学、19 项尿液分析和 16 项器官重量。
雄性猕猴的淋巴细胞、嗜碱性粒细胞和大型未染色细胞的绝对计数和相对计数较高，而中性粒细胞则较低。在血清生化方面，雄性猕猴的 IP、GGT、ALP 和 TCHO 高于雌性。
确定了适合临床前安全性分析的历史数据。
