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RegisterEUFEPS/AAPS meeting [Conferences / Workshops]
Hello everyone,
I was able to attend the recent EUFEPS/AAPS Harmonization initiative conference and it was great hearing from many of the highly regarded minds in Bioequivalence from industry, academia, regulatory, etc.
I would be curious to get feedback from those who were there as to what you thought of what was discussed. In particular, I found the discussion regarding the attempts to harmonize the use of scaled BE between the FDA, EMA and Canada quite interesting (i.e. AUC and Cmax for FDA, whereas EMA only allows for Cmax). However, there seemed to be no overall conclusion made, unfortunately.
Regards,
BRB
I was able to attend the recent EUFEPS/AAPS Harmonization initiative conference and it was great hearing from many of the highly regarded minds in Bioequivalence from industry, academia, regulatory, etc.
I would be curious to get feedback from those who were there as to what you thought of what was discussed. In particular, I found the discussion regarding the attempts to harmonize the use of scaled BE between the FDA, EMA and Canada quite interesting (i.e. AUC and Cmax for FDA, whereas EMA only allows for Cmax). However, there seemed to be no overall conclusion made, unfortunately.
Regards,
BRB
Complete thread:
- EUFEPS/AAPS meetingBRB 2016-09-20 19:12
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- A long way to go… Helmut 2016-09-20 20:18
- GMR restrictions? mittyri 2016-09-21 00:32
- A long way to go… Helmut 2016-09-20 20:18
Ing. Helmut Schütz