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Register5% from Cmax/request from MoH RF [Study Assessment]
Hi all!
I have got a strange request from RU authorities recently. Namely 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. What is your opinion/comments regarding that bolded phrase? I find it strange and not like in the EMA GL.
Edit: Category changed; see also this post #1. [Helmut]
I have got a strange request from RU authorities recently. Namely 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. What is your opinion/comments regarding that bolded phrase? I find it strange and not like in the EMA GL.
Edit: Category changed; see also this post #1. [Helmut]
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Best regards
Beholder
Best regards
Beholder
Complete thread:
- 5% from Cmax/request from MoH RFBeholder 2016-05-23 16:23 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 5% from Cmax/request from MoH RF Helmut 2016-05-23 16:41
- "minimal average"?? ElMaestro 2016-05-23 17:28
Ing. Helmut Schütz