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

posted by vixen – Czechia, 2021-07-30 20:44 (1223 d 07:04 ago) – Posting: # 22488
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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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