Bioequivalence and Bioavailability Forum

Hi again,

❝ How would you handle the n_k being variable for every batch in these equations?

Maybe I didn't understand your question then. I apologise if this was the case.
n_k 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