Bioequivalence and Bioavailability Forum • No acceptance criteria widening for AUC in Europe

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

posted by vixen – Czechia, 2021-07-30 20:44 (852 d 01:00 ago) – Posting: # 22488
Views: 1,854

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:

you demonstrate in a replicate design study that the reference IS CV for Cmax is above 30%,
a wider difference in Cmax is considered clinically irrelevant based on a sound clinical justification

Cheers,
vixen

Complete thread:

What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG prasad.v 2021-07-29 10:33 [Regulatives / Guidelines]
- No acceptance criteria widening for AUC in Europevixen 2021-07-30 18:44
- No reference-scaling for NTIDs Helmut 2021-08-02 14:57
- What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG drgunasakaran1 2021-08-06 08:47