相关实验视频
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Murine Fetal Echocardiography
Published on: February 15, 2013
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在胎儿大鼠骨评估中的标准和术语的协调
L M Posobiec1, C Kopp2, S M Murzyn1
1GlaxoSmithKline, Philadelphia, PA, USA.
Birth defects research
|May 27, 2023
概括
这项研究调查了关于胎儿骨检查术语的实验室,以协调发育毒性 (DT) 研究中发现的分类. 建议旨在提高监管提交的异常识别的一致性.
科学领域:
- 毒理学 毒理学 毒理学
- 发育生物学 发展生物学
- 形态学 形态学 形态学
背景情况:
- 胎儿骨检查在发育性毒性 (DT) 研究中至关重要.
- 目前用于DT研究中的骨发现分类的术语缺乏标准化.
- 识别正常变异的不一致标准阻碍了实验室间的一致性.
研究的目的:
- 了解DT研究中骨发现的当前术语.
- 确定分类胎儿骨中偏离正常的标准.
- 促进术语的协调,提高实验室间的一致性.
主要方法:
- 一项调查分发给北美和欧洲的实验室进行胎儿骨检查.
- 调查的设计是基于发展异常术语的国际建议.
- 答案由专家胎儿形态学家审查,以产生建议.
主要成果:
- 调查答复提供了对目前用于分类骨发现的实践的见解.
- 专家审查导致了对首选术语和标准的建议.
- 具体建议侧重于对Sprague Dawley (SD) 胎儿大鼠的骨观察.
结论:
- 这些建议旨在补充现有的国际指导方针.
- 协调的术语和标准将改善DT研究的实验室间一致性.
- 胎儿骨发现的标准化记录将有利于监管提交,包括使用非临床数据交换标准 (SEND) 的监管提交.
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