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RegisterIn-vitro equivalence [General Statistics]
Hi Alex,
Absolutely correct re. the ignorance of ref. variability. However I am not sure in the context of this question that within-batch variability is the concern, given Martin's question "assuming normal distribution and independent replicates". In fact, when we look at between-batches (which I think is the likely aim for this QbD exercise) then the replicates within batches can certainly not be said to be independent or uncorrelated. In such situations, I think the theoretical way out is to use a mixed model. But it all depends on the purpose.
But as always I could be wrong, so...
Martin, do you wish to characterise the process performace within-batch or between-batch?
❝ Wouldn't that ignore the variability of the reference batch? It would be identical to an one-sample t-test to the reference PE for each batch. What if the focus is more on testing for equivalence than on testing for difference?
Absolutely correct re. the ignorance of ref. variability. However I am not sure in the context of this question that within-batch variability is the concern, given Martin's question "assuming normal distribution and independent replicates". In fact, when we look at between-batches (which I think is the likely aim for this QbD exercise) then the replicates within batches can certainly not be said to be independent or uncorrelated. In such situations, I think the theoretical way out is to use a mixed model. But it all depends on the purpose.
But as always I could be wrong, so...
Martin, do you wish to characterise the process performace within-batch or between-batch?
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- In-vitro equivalence martin 2012-05-17 15:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- In-vitro equivalence ElMaestro 2012-05-19 01:35
- In-vitro equivalence martin 2012-05-19 10:28
- In-vitro equivalence ElMaestro 2012-05-19 13:55
- In-vitro equivalence Alex 2012-05-22 11:10
- In-vitro equivalenceElMaestro 2012-05-22 14:08
- In-vitro equivalence martin 2012-05-22 17:00
- In-vitro equivalence ElMaestro 2012-05-22 18:36
- In-vitro equivalence martin 2012-05-22 17:00
- In-vitro equivalenceElMaestro 2012-05-22 14:08
- In-vitro equivalence Alex 2012-05-22 11:10
- In-vitro equivalence ElMaestro 2012-05-19 13:55
- In-vitro equivalence martin 2012-05-19 10:28
- In-vitro equivalence ElMaestro 2012-05-19 01:35
Ing. Helmut Schütz