LD50

尚坡

A品种中有1个原料、4个辅料，分别重量的为100Kg（甲）、20Kg（乙）、20kg（丙).10kg(丁)、8kg(戊)。其中LD50分别为1、12、100、30、11.5、123，。应该用哪个LD50的值呢？

大草原制药人

应该用此成品药的LD50.

尚坡

大草原制药人 发表于 2017-8-17 17:06
应该用此成品药的LD50.

那岂不是测残留时也要测成品的残留量，成品的残留量怎么测

冷血无情

测试的是API残留 很少见辅料残留 除非 辅料有剧毒

lik002

成品质量标准里都有对相关项目的控制，所以一半不考虑原辅料的残留

尚坡

冷血无情 发表于 2017-8-17 19:54
测试的是API残留 很少见辅料残留 除非 辅料有剧毒

用列出来辅料的LD50么

冷血无情

芥末子推 发表于 2017-8-17 22:15
用列出来辅料的LD50么

似乎很少见 没听说过

beiwei5du

LD50是和动物以及给药途径相关的，首先你得至少确认这些LD50是否和下一个品种的给药途径相同，以及这些LD50是基于相同的动物模型的出来的，否则比较没有意义。
另一方面下文选自PDA TR29,仅供参考！
10.12   Excipients
The excipients used for a drug product should be considered in the cleaning validation program. One
issue for excipients is the possible effect on cleaning of  a drug product. This effect is generally more
pronounced for solid dosage products, where the excipient may be a coating or other functional mate-
rial designed to retard dissolution. This is one reason why some companies prefer to use a laboratory
cleaning study, as compared to only evaluating the solubility of  the active ingredient, to determine the
difficulty of  cleaning of  different products in a grouping approach.

Unless the excipient has some kind of  unusual toxicity, limits are generally not set for excipients in
a cleaning validation protocol. A case where limits may be set for excipients is where the excipient
is known to have a significant effect on the performance of  the next manufactured product, such as
complexing with the API to reduce bioavailability. However, it should be recognized that in all cases,
residues of  excipients after cleaning should be such that the equipment is visually clean. A surface
which is not “visually clean” due to a high level of  an excipient should be generally considered a clean-
ing validation failure.

beiwei5du

大草原制药人 发表于 2017-8-17 17:06
应该用此成品药的LD50.

如果选的是成品中API计算限度的话，也不会用到LD50,毕竟一条生产线相同，剂型相同，既然是成品，TDD等都有相应的数据，为什么还用LD50???