No acceptance criteria widening for AUC in Europe [Regulatives / Guidelines]

posted by vixen – Czechia, 2021-07-30 20:44 (484 d 15:16 ago) – Posting: # 22488
Views: 1,635

Hi Prasad,

Can't comment on the WHO or HKG, but in Europe you would be only allowed to widen the acceptance criteria for Cmax (not for AUC) and under the conditions that:Cheers,
vixen

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