Population BE [PBE] [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2025-01-09 15:46 (32 d 10:39 ago) – Posting: # 24335
Views: 705

Hi jdfr,

❝ Should MSW be set to zero ad follow the same approach? On the example it is mentioned that when m = 1, E2 and E4s should not be used, so I believe that it would be the case, but would you do it in another way?

❝ Should one test MSW as the variation within batch and not within canister?


No, MSW is variability within units. This quantity is relevant when you test across stages.
If there is just one stage then you have no way to estimate a within-unit-variability, hence E2, E4 are left out.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,379 posts in 4,913 threads, 1,661 registered users;
254 visitors (0 registered, 254 guests [including 12 identified bots]).
Forum time: 02:25 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5