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考虑胃肠道发育在监管性幼年研究中选择物种的问题。

Consideration of the Development of the Gastrointestinal Tract in the Choice of Species for Regulatory Juvenile Studies.

机构信息

Sequani Limited, Herefordshire, United Kingdom.

出版信息

Birth Defects Res. 2018 Jan 15;110(1):56-62. doi: 10.1002/bdr2.1119. Epub 2017 Sep 5.

DOI:10.1002/bdr2.1119
PMID:28872769
Abstract

Although the rat is close to being the automatic choice for regulatory juvenile toxicity studies, there are several shortcomings in this model. Choosing a species should take into serious consideration the importance of gastrointestinal tract development in the period before weaning as this may have a major effect on exposure. A comparison of the anatomical changes in the stomach and small intestine of mini-pig and rat show that the mini-pig is a far closer model for man than is the rat, although there are a few unusual aspects of small intestinal development in the mini-pig. Considerations of the development of the gastrointestinal tract and choice of species have the potential to affect safety assessment and should be a prime consideration when planning an investigation. Birth Defects Research 110:56-62, 2018. © 2017 Wiley Periodicals, Inc.

摘要

虽然大鼠接近成为监管性幼年毒性研究的自动选择,但该模型存在几个缺点。选择物种时应认真考虑断奶前胃肠道发育的重要性,因为这可能对暴露产生重大影响。小型猪和大鼠胃和小肠解剖变化的比较表明,小型猪比大鼠更接近人类模型,尽管小型猪的小肠发育有一些不寻常的方面。考虑到胃肠道的发育和物种的选择有可能影响安全性评估,因此在计划研究时应优先考虑。出生缺陷研究 110:56-62, 2018. © 2017 Wiley Periodicals, Inc.

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