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两个问题,想请教下各位:1、2023GMP指南《口服固体制剂与非无菌吸入制剂》分册P326页,规定以LD50计算NOEL:NOEL(mg)=LD50(mg/kg)*BW (kg)/2000; 来源于APIC,. 如题所问。没有毒理学知识背景请教各位前辈。Q3C原文如下:PDE is derived from the no-observed-effect level (NOEL) , or the lowest-observed effect level (LOEL) in ...,ICHQ3C. 例如印尼语 Natal 借自葡萄牙语Natal (而非荷兰语Kerstmis);越南语 Lễ Giáng Sinh 则是意译的“降生的节日”,受法语影响,也曾使用 Noel, Nô-en (越化的读法)。
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搬运自丁香园。1.大家有兴趣可以自己检索一下上述这些毒理学数据,可以以某个具体化合物为例,很明显的可以看出来动物的LD50、TDL0、人的PDE之间是不是有明确的线性关系,. 丙醛的NOEL(no observed effect level)值, 由于需要计算丙醛的PDE(permitted daily exposure)值,需要知道NOEL值,请问相关数据在哪里查询? 如题:因注册需要计算某一药物的PDE值,目前手头能查到的资料只有该药物的LD50值,不知如何推导出PDE值?或有有其它什么办法算出PDE值?,如何计算药物的PDE,蒲公英 - 制药技术的传播.
已知OEL,计算NOEL,请问安全系数是多少。口服固体制剂直接100吗?各个因子是什么意思?,根据OEL计算的NOEL值,蒲公英 - 制药技术的传播者 GMP理论的实践者
各位同行和大神们,APIC还有其他很多指南里提到清洁验证里计算ADE或者PDE需要用到NOEL或LOEL的数据,搜索了下以前有蒲友发过类似的帖子,也尝试过去EMA或者FDA网站上找过这. 请教共线风险评估中PDE值计算时,关于NOEL的计算,可以直接套用公式 NOEL=LD50*70/2000 吗(亚洲人50Kg)?还有F4的取值不太懂,应该如何取值呢? 补充内容 ...,请. NOAEL和NOEL这两个概念,到底该怎么样区分?分别代表什么意思?总是模糊不清,请大家帮助分析一下。谢谢!
