Are Health-Based Exposure Limits (HBELs) required for all medicinal products? - 分享质量人的知识和经验

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Are Health-Based Exposure Limits (HBELs) required for all medicinal products?

EMA

Are Health-Based Exposure Limits (HBELs) required for all medicinal products?
是否所有药品均需要订立基于健康的暴露限（HBEL）？

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kk444555 一阶会员用户来自于: 广东省深圳市
2023-10-17 22:41

Yes, HBELs should be established for all medicinal products. The toxicological or pharmacological data, on which the HBEL calculation relies, requires periodical re- assessment throughout a product’s lifecycle.
是的，应为所有药品建立HBEL。HBEL计算所依赖的毒性或药学数据需要在产品生命周期内定期进行重新评估。

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发布时间: 2023-10-17 22:40

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