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

登录

1: 关注

906: 浏览

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）？

好问题 0 评论收藏举报

查看全部 1 个回答

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。

赞同 0 0评论

关于作者

: 似水流年 二阶会员
这家伙很懒，还没有设置简介

131: 回答

146: 文章

115: 问题

问题动态

发布时间: 2023-10-17 22:40

更新时间: 2023-10-17 22:41

关注人数: 1 人关注

相关问题

What are the “systems” in “computer or related systems” in § 211.68?: 933 浏览 1 关注 1 回答 0 评论

Could you please explain if drying conditions are required?: 978 浏览 1 关注 1 回答 0 评论

could the software information in the devicecertificate be updated during Registration Renewal?: 1011 浏览 1 关注 1 回答 0 评论

Can the cybersecurity descriptiondocument be submitted within the software descriptiondocument?: 1127 浏览 1 关注 1 回答 0 评论

What are the storage conditions for EDQM reference standards?: 998 浏览 1 关注 1 回答 0 评论

How to determine the naming rules for softwareversion?: 1067 浏览 1 关注 1 回答 0 评论

can we onlycompare the key performances?: 1167 浏览 1 关注 1 回答 0 评论

Why is FDA concerned with the use of shared login accounts for computer systems?: 917 浏览 1 关注 1 回答 0 评论

What is software core algorithm?: 946 浏览 1 关注 1 回答 0 评论

Is the use of LD50 to determine Health-Based Exposure Limits for drug products acceptable?: 973 浏览 1 关注 1 回答 0 评论

推荐内容

问活性物质标准是否需要明确在生产过程中使用了鱼蛋白胨，并且组胺是控制在协定范围内的特定杂质？: 894 浏览 1 关注 1 回答 0 评论

问 What is the difference betweenprocess validation and design space verification?: 985 浏览 1 关注 1 回答 0 评论

问 How should design spaceverification approach be addressed in the pharmaceutical quality system?: 996 浏览 1 关注 1 回答 0 评论

问杀外寄生虫药物是否可以与其它类别人用或兽用药品在共用设备中生产或进行内包装？: 1028 浏览 1 关注 1 回答 0 评论

问基于问卷调查、文件评审、ISO 9000认证、分析测试结果和与供应商的历史经验进行远程评估是否可以接受?: 944 浏览 1 关注 1 回答 0 评论

问委托生产方在支持HBEL评估的数据方面有什么职责？: 856 浏览 1 关注 1 回答 0 评论

问 How is a design space initiallydeveloped and verified at commercial scale?: 959 浏览 1 关注 1 回答 0 评论

问 How can limits for cleaning purposes be established?: 878 浏览 1 关注 1 回答 0 评论

问 Is the use of LD50 to determine Health-Based Exposure Limits for drug products acceptable?: 973 浏览 1 关注 1 回答 0 评论

问 What if unexpectedresults/events are obtained during the design space verification studies?: 1000 浏览 1 关注 1 回答 0 评论

技术支持 WeCenter © 2024 粤ICP备2023143277号-1