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药物诱导的损伤:挑战和机遇
Skylar Connor1, Ruth A Roberts2,3, Weida Tong1
1National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR 72079, United States.
Toxicology research
|August 6, 2024
概括
药物诱导损伤 (DIKI) 是患者和药物开发的一个重大问题. 需要新的方法来更早地检测DIKI,因为目前的生物标志物缺乏灵敏度.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
背景情况:
- 药物诱导损伤 (DIKI) 是一种常见的不良事件,与急性损伤,慢性病和末期功能衰竭有关.
- DIKI影响了14-26%的成人和16%的儿科病例,导致显著的临床前 (8%) 和临床 (9%) 药物开发失败.
- 目前的DIKI生物标志物,血清肌和血液尿素,缺乏早期检测的敏感性和特异性.
研究的目的:
- 在临床前和临床环境中讨论DIKI评估.
- 审查FDA和EMA接受的尿路生物标志物用于DIKI监测.
- 在早期药物发现中探索新的DIKI生物标志物开发的新方法方法 (NAM).
主要方法:
- 关于DIKI的当前文献的审查.
- 监管机构 (FDA,EMA) 接受的尿路生物标志物的分析.
- 对生物标志物发现的新方法方法 (NAMs) 的检查.
主要成果:
- 标准的DIKI生物标志物 (血清肌素,BUN) 不足以进行早期检测.
- 现有的尿路生物标志物被接受用于临床前研究和有限的临床使用.
- 对于开发新型,早期的DIKI生物标志物而言,NAM显示出前景.
结论:
- 对于早期DIKI检测而言,敏感和特定的生物标志物至关重要.
- 监管所接受的生物标志物存在,但有局限性.
- 在药物发现中,NAM为推进DIKI生物标志物开发提供了一个有前途的途径.
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