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Updated: Jul 7, 2026

Intravenous Endotoxin Challenge in Healthy Humans: An Experimental Platform to Investigate and Modulate Systemic Inflammation
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建立内毒素限值,以提高体外免疫性风险评估的可靠性

Yun Hee Jeong1, Gillian Lennon1, Geertruida Veldman2

  • 1In Vitro Immunosafety, Development Biological Sciences, Abbvie Bioresearch Center, Worcester, MA, USA.

mAbs
|February 2, 2025
PubMed
概括

产品污染物,如内毒素,可以导致T细胞增殖测定生物治疗免疫性假阳性. 标准化协议对于精确评估蛋白质疗法的风险至关重要.

关键词:
最后毒素 (Endotoxin) 是一种内毒素.T细胞的增殖和扩散.免疫性风险评估免疫性风险评估在体外测定试验.

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Toxicity Testing in Animals01:23

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Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...