Population BE [PBE] [Regulatives / Guidelines]

posted by jdfr – Portugal, 2025-01-09 10:16 (32 d 16:16 ago) – Posting: # 24333
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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?

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