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遗传毒理学
遗传毒理学

对遗传毒性进行评估至关重要

遗传毒理学

遗传毒性评价是所有受试物安全性评价的重要组成部分,包括药品、工业化学品、杀虫剂、杀菌剂、食品添加剂、化妆品和兽用药,与旨在保护人类和动物健康的国际法规相关。一般来说,对人用药遗传毒性的评估遵循循序渐进的原则,首先进行体外筛选试验,然后进行用于IND申报的标准组合试验。

基因毒理学 - 遗传毒理学

方达医药提供遗传毒理学标准组合试验,以满足 IND申报的所有法规要求。

遗传毒理学试验

  • 细菌回复突变试验(OECD TG 471)
    • Ames 试验(GLP 和Non-GLP)
  • 体外微核试验(OECD TG 487)
    • 使用CHO、人淋巴细胞和小鼠淋巴瘤细胞
  • 体内微核试验(OECD TG 474)
    • 大鼠和小鼠(血液和骨髓)

 

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