EMA: scaling for AUC = utopia [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2021-08-03 12:54 (53 d 16:53 ago) – Posting: # 22501
Views: 1,049

Hi kratos,

» Just wanted to understand if the EMA would also start accepting scaling for AUC;
» There are several locally acting products where the AUC could be more variable than the Cmax parameter.


» At the moment it appears only the EMA has restricted scaling to Cmax parameter …

Almost correct. Acceptable for MR products’ partial AUCs and Cτ,ss as well.

» … while other agencies have extended it to AUC as well.

Which ones? At least, none of the ones applying Average Bioequivalence with Expanding Limits (ABEL). Given, Health Canada accepts ABEL for AUC only.
Reference-scaled Average Bioequivalence (RSABE) – acceptable by the U.S. FDA and China’s CDE for any PK metric – is another cup of tea.

» Please, your thoughts on the same.

IMHO, it’s high time to revise the EMA’s GL of 2010. The mills of God grind slowly.
Perhaps the ICH works faster.

Dif-tor heh smusma 🖖
Helmut Schütz

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