Population BE [PBE] [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2025-01-07 14:50 (7 d 22:59 ago) – Posting: # 24326
Views: 434

Hi jdfr,

❝ Should one use log transformed data? In step 1 it says so, but when calculating ED from table in step 3, the final value comes from calculating using mean values from the untransformed variable.


From the top of my head I think the only thing they do not tell you in the guidance is that the sample data is already ln-tranformed.

❝ If I were to do an ANOVA to extract MSB and MSW, should I use a single effect of the containers or add any other effect to it? Doing so didn't lead me to achieve the same results as the ones found in the example.


You would need to combine some mean squares for MSB as variability between comes from different units and different batches. I do not readily have a recipe. I am sure it can be worked out pretty easily, but again why do it when the guidance has a perfect example with equations for it?


❝ It might be easier that way, but I am having trouble in computing the numerator of both MSB and MSW. Any tip?



❝ Also, could you clarify "Xbar ijk is the average m life stages for ith bottle in batch # j", please?


Xbarijk. is to be understood as:
The value of X for the i'th unit of the j'th batch for the k'th product averaged over the m stages of your data.

Pass or fail!
ElMaestro

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