Population BE [PBE] [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2025-01-08 12:02 (33 d 15:50 ago) – Posting: # 24330
Views: 855

Hi jdfr,

❝ I was wondering if that would be the way to calculate it, but it seems it isn't. Do you have any clarification on this topic?


Xbarijk. is very simple:
Let us say you look at the 8th unit from batch 2 of the ref product. Let us say that you are coding ref as k=1 (which would most likely imply that you code Test as k=2). So we are looking at samples with i=8, j=2 k=1.
Assume on the ln-scale you have three measurements:
Beginning: 1.6
Middle: 1.8
End: 1.7

Let us further say you code Beginning as s=1, middle as s=2, end as s=3.
So, in fact you have
X8211=1.6
X8212=1.8
X8213=1.7

Averaging across stages you get Xbarijk.=1.7.
This is the average observation across stages for that specific unit in question.

Of course in FDA's sample set they did not code units nicely as i=1,2,3... It is up to you to handle that part. Same for batches, stages.

Pass or fail!
ElMaestro

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