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studious_117 ☆ USA, 2026-01-26 21:35 (128 d 03:02 ago) Posting: # 24555 Views: 1,311 |
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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) |
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ElMaestro ★★★ Denmark, 2026-01-27 21:14 (127 d 03:22 ago) @ studious_117 Posting: # 24556 Views: 1,192 |
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Hi studious_117, ❝ 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? Yes it is. The equations do not require balance in terms of units-per-batch-between-products or batches-per-product. Just plug the data into those equations and you're good to go  Full throttle. May your upper Eta limit be negative.  — Pass or fail! ElMaestro |
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studious_117 ☆ USA, 2026-01-27 21:34 (127 d 03:02 ago) @ ElMaestro Posting: # 24557 Views: 1,143 |
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❝ […] The equations do not require balance in terms of units-per-batch-between-products or batches-per-product. Just plug the data into those equations and you're good to go ❝ Full throttle. May your upper Eta limit be negative. How would you handle the nk being variable for every batch in these equations? Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
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ElMaestro ★★★ Denmark, 2026-01-27 22:47 (127 d 01:50 ago) @ studious_117 Posting: # 24558 Views: 1,089 |
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Hi again, ❝ How would you handle the nk being variable for every batch in these equations? Maybe I didn't understand your question then. I apologise if this was the case. nk is "Number of canisters or bottles per batch", for the k'th product. There is no provision in the guidance for varying the number of cans (bottles) per batch within a product. I struggle to see how a carefully planned experiment would involve varying the number of cans across batches. Would there be any advantage of it?!? If you have a dataset with this kind of variation then I'd suggets to: 1. Evaluate if a bootstrap/resampling approach can get you somewhere 2. Plan it differently next time — Pass or fail! ElMaestro |
Ing. Helmut Schütz