Reference value of hematologic, urologic, and organ weights of 2- to 4-year-old long-tailed macaques (Macaca fascicularis fascicularis) in the context of toxicological studies.

BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSION Historical data suitable for preclinical safety analysis were determined.