APIC验证指南的疑问

beiwei5du · 发表于 2015-5-28 23:45:18

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Example 3: Acceptance criteria based on Acceptable Daily Exposure
Product A will be cleaned out. The product has an ADE of 2 mg and the batch size is 200 kg. The next product B has a standard daily dose of 250 mg and the batch size is 50 kg. Calculate the MACO for A in B.
      0.002 (mg) x 50 000 000 (mg)
MACO = ------------------------------------       = 400 (mg)
                  250 (mg)

Result:MACO is 0.4 g (400 mg)

请问这个0.002mg是不是应改为2mg啊！

beiwei5du · 发表于 2015-5-28 23:51:54

APIC中写的公式是这样的：
ADEprevious x MBSnext
MACO = ------------------------------
TDDnext
MACO Maximum Allowable Carryover: acceptable transferred amount from the previous product into your next product (mg)
ADE Acceptable Daily Exposure (mg/day)
TDDnext Standard Therapeutic Daily Dose for the next product (mg/day)
MBSnext Minimum batch size for the next product(s) (where MACO can end up) (mg)

但是算出结果400g也太多了吧！应该按照通用标准计算吧！？？

292314614 · 发表于 2015-5-29 08:44:40

这个是MTDD0.1%啊，故你的2mg得乘以0.1%

呼呼_802 · 发表于 2015-5-29 08:50:19

400g也不算多吧，400g除以200kg，残留量2ppm，我没算错吧

呼呼_802 · 发表于 2015-5-29 08:53:40

用通用标准10ppm计算的结果应该更大吧

beiwei5du · 发表于 2015-5-29 12:25:40

292314614 发表于 2015-5-29 08:44
这个是MTDD0.1%啊，故你的2mg得乘以0.1%

不是TDD, The product has an ADE of 2 mg是ADE2mg/day呢！

beiwei5du · 发表于 2015-5-29 12:26:47

呼呼_802 发表于 2015-5-29 08:50
400g也不算多吧，400g除以200kg，残留量2ppm，我没算错吧

400g处于下批的量为50kg为8ppm

呼呼_802 · 发表于 2015-5-29 12:31:12

beiwei5du 发表于 2015-5-29 12:26
400g处于下批的量为50kg为8ppm

对，我弄错了，应该除以下一规格产品的批量

[质量保证QA] APIC验证指南的疑问

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