Bioequivalence and Bioavailability Forum • Population BE [PBE]

Population BE [PBE] [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2025-01-09 15:46 (177 d 10:10 ago) – Posting: # 24335
Views: 4,517

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:

Population BE [PBE] jdfr 2024-12-05 16:34 [Regulatives / Guidelines]
- Population BE [PBE] ElMaestro 2024-12-17 22:50
  - Population BE [PBE] jdfr 2025-01-06 11:14
    - Population BE [PBE] ElMaestro 2025-01-06 12:52
      - Population BE [PBE] jdfr 2025-01-07 12:08
        
        Population BE [PBE] ElMaestro 2025-01-07 13:50
        
        Population BE [PBE] jdfr 2025-01-07 17:10
        
        Population BE [PBE] ElMaestro 2025-01-07 18:55
        
        Population BE [PBE] jdfr 2025-01-08 10:13
        
        Population BE [PBE] ElMaestro 2025-01-08 11:02
        
        Population BE [PBE] jdfr 2025-01-08 17:45
        Population BE [PBE] jdfr 2025-01-09 09:16
        
        Population BE [PBE]ElMaestro 2025-01-09 14:46