Beholder
★    

Russia,
2016-05-23 18:23
(2866 d 02:37 ago)

Posting: # 16354
Views: 3,791
 

 5% 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]

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Beholder
Helmut
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Vienna, Austria,
2016-05-23 18:41
(2866 d 02:20 ago)

@ Beholder
Posting: # 16355
Views: 3,174
 

 5% from Cmax/request from MoH RF

Hi Beholder!

❝ […] 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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ElMaestro
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Denmark,
2016-05-23 19:28
(2866 d 01:33 ago)

@ Beholder
Posting: # 16356
Views: 3,105
 

 "minimal average"??

Hi Beholder,

minimal average of Cmax makes no sense in this situation. Numerically, it might make sense if we talked some quantity derived across multiple studies but I'd have zero idea how to use such info for any purpose :-)

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