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RegisterPBE Calculations when Number of Containers per Batch is Not Uniform [General Statistics]
Hello, I am trying to do a PBE analysis per the FDA guidelines on Budesonide.
However, when it comes to calculating the MSW, the MSB, Confidence intervals and so forth, what is the correct procedure for determining these values?
The FDA guidelines showed an example where there are 10 containers for every batch and this was uniform. What if the containers varied? Say some batches had 10 and others had 30 i.e nk = 10 or 30.? This is assuming the number of life stages and number of batches per reference and test products remained constant i.e m = 3 and lk = 6
Is this even possible?
![[image]](img/uploaded/image929.png)
However, when it comes to calculating the MSW, the MSB, Confidence intervals and so forth, what is the correct procedure for determining these values?
The FDA guidelines showed an example where there are 10 containers for every batch and this was uniform. What if the containers varied? Say some batches had 10 and others had 30 i.e nk = 10 or 30.? This is assuming the number of life stages and number of batches per reference and test products remained constant i.e m = 3 and lk = 6
Is this even possible?
Complete thread:
- PBE Calculations when Number of Containers per Batch is Not Uniformstudious_117 2026-01-26 20:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PBE Calculations when Number of Containers per Batch is Not Uniform ElMaestro 2026-01-27 20:14
- PBE Calculations when Number of Containers per Batch is Not Uniform studious_117 2026-01-27 20:34
- PBE Calculations when Number of Containers per Batch is Not Uniform ElMaestro 2026-01-27 21:47
- PBE Calculations when Number of Containers per Batch is Not Uniform studious_117 2026-01-27 20:34
- PBE Calculations when Number of Containers per Batch is Not Uniform ElMaestro 2026-01-27 20:14
Ing. Helmut Schütz