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RegisterEMA: scaling for AUC = utopia [BE/BA News]
posted by Helmut 
– 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.
Correct.
» 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.
» 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.
Correct.
» 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
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- WHO: scaling for AUC? Ohlbe 2017-06-12 13:29 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- WHO: Chapeau! Helmut 2017-06-12 23:31
- WHO: Chapeau! ElMaestro 2017-06-13 00:08
- WHO: Chapeau! nobody 2017-06-13 09:28
- WHO: Chapeau! Helmut 2019-06-10 11:23
- WHO: Chapeau! ElMaestro 2019-06-11 18:51
- WHO: Chapeau! ElMaestro 2017-06-13 00:08
- WHO: scaling for AUC confirmed Ohlbe 2021-07-02 10:31
- No comparison of variabilities any more 😀 Helmut 2021-07-02 15:11
- WHO: scaling for AUC confirmed kratos 2021-08-03 10:38
- EMA: scaling for AUC = utopiaHelmut 2021-08-03 12:54
- WHO: Chapeau! Helmut 2017-06-12 23:31
Ing. Helmut Schütz