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食蟹猴胃部评估:非临床安全性研究中标准取样程序的建议。

Evaluation of the cynomolgus monkey stomach: recommendations for standard sampling procedures in nonclinical safety studies.

作者信息

Vidal Justin D, Mirabile Rosanna C, Thomas Heath C

机构信息

GlaxoSmithKline, King of Prussia, Pennsylvania 19406-0939, USA.

出版信息

Toxicol Pathol. 2008 Feb;36(2):250-5. doi: 10.1177/0192623307312700. Epub 2008 Mar 25.

DOI:10.1177/0192623307312700
PMID:18364462
Abstract

The cynomolgus macaque is the most commonly used nonhuman primate in nonclinical toxicity testing, but the macroscopic and microscopic anatomy of the stomach in the cynomolgus macaque is poorly described. To develop a reliable sampling method for histologic evaluation of the cynomolgus macaque stomach in regulatory toxicity studies, the stomachs of control animals were prospectively evaluated using an extensive sectioning pattern. The stomach of the cynomolgus macaque differs from that described for the human stomach and has a prominent fundus that lacks parietal cells. A description of the macroscopic and microscopic anatomy is presented along with a recommended sectioning pattern for nonclinical toxicity studies and discussion of species differences. A thorough understanding of normal anatomy and species comparisons are critical to interpretation of potential toxicity findings and assessment of risk in humans.

摘要

食蟹猕猴是在非临床毒性试验中最常用的非人灵长类动物,但对食蟹猕猴胃的大体和微观解剖描述较少。为了开发一种可靠的采样方法,用于在监管毒性研究中对食蟹猕猴胃进行组织学评估,我们采用广泛的切片模式对对照动物的胃进行了前瞻性评估。食蟹猕猴的胃与人类胃的描述不同,有一个突出的胃底,缺乏壁细胞。本文介绍了大体和微观解剖结构,以及非临床毒性研究推荐的切片模式,并讨论了物种差异。深入了解正常解剖结构和物种比较对于解释潜在毒性发现和评估人类风险至关重要。

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