Bioequivalence and Bioavailability Forum • Population BE [PBE]

Population BE [PBE] [Regulatives / Guidelines]

posted by jdfr – Portugal, 2025-01-09 10:16 (6 d 04:22 ago) – Posting: # 24333
Views: 251

Hi ElMaestro,

A question arose, when thinking about examples. Imagining that no canister replication (life stage) was tested (m = 1), what considerations should be taken into account?

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?

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