Relation between statistics and treatment-related changes obtained from toxicity studies in rats: if detected a significant difference in low or middle dose for quantitative values, this change is considered as incidental change?

被引：4

作者：

Kobayashi, Katsumi ^{[1
]}

Sakuratani, Yuki ^{[1
]}

Abe, Takemaru ^{[1
]}

Nishikawa, Satoshi ^{[1
]}

Yamada, Jun ^{[1
]}

Hirose, Akihiko ^{[2
]}

Kamata, Eiichi ^{[2
]}

Hayashi, Makoto ^{[1
,3
]}

机构：

[1] Natl Inst Technol & Evaluat, Chem Management Ctr, Shibuya Ku, Tokyo 1510066, Japan

[2] Natl Inst Hlth Sci, Setagaya Ku, Tokyo 1588501, Japan

[3] An Pio Ctr, Iwata, Shizuoka 4371213, Japan

来源：

JOURNAL OF TOXICOLOGICAL SCIENCES | 2010年 / 35卷 / 01期

关键词：

Toxicity; Rodents; Statistics; Historical control data; Incidental change; Standard deviation and error; SUBCHRONIC ORAL TOXICITY; SPRAGUE-DAWLEY RATS; F344; RATS; SUBACUTE TOXICITY; 90-DAY TOXICITY; WISTAR RATS; B6C3F1; MICE; COLOR; ACID; ACETATE;

D O I：

10.2131/jts.35.79

中图分类号：

R99 [毒物学（毒理学）];

学科分类号：

100405 ;

摘要：

The purpose of a toxicity test is to determine the no-observed-effect level (NOEL) of test substance through biological and pharmacological techniques. If the low dose not does show statistically significant and biologically relevant changes in the data evaluated in a study, the usual practice is to consider this dose as the NOEL. To overcome this, 6 types of techniques that seemed to be appropriate are presented in this paper by investigating the results of several domestic and foreign theses on toxicology. The most appropriate techniques appear to be the trend test, comparison between treatment group and historical control by t-test, and confirmation that all individual Values lie within the 95% confidence interval (2 SD) of the historical control value, if a significant difference is admitted in the low dose.

引用

页码：79 / 85

页数：7