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Register5% from Cmax/request from MoH RF [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2016-05-23 18:41 (3685 d 21:25 ago) – Posting: # 16355
Views: 4,936
Hi Beholder!
Very strange indeed. Never came across the term minimal average Cmax in a study.
Russian invention?
Very strange indeed. In the EMA’s GL it means 5% of the subject’s Cmax in each profile.
❝ […] I was requested to add the statement that the pre dose concentration should not be more than 5% from minimal average Cmax in a study otherwise the data from that volunteer must be excluded from the statistical analysis.
Very strange indeed. Never came across the term minimal average Cmax in a study.
❝ What is your opinion/comments regarding that bolded phrase?
Russian invention?
❝ I find it strange and not like in the EMA GL.
Very strange indeed. In the EMA’s GL it means 5% of the subject’s Cmax in each profile.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- 5% from Cmax/request from MoH RF Beholder 2016-05-23 16:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 5% from Cmax/request from MoH RFHelmut 2016-05-23 16:41
- "minimal average"?? ElMaestro 2016-05-23 17:28
Ing. Helmut Schütz