5% from Cmax/request from MoH RF [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2016-05-23 18:41 (3184 d 02:03 ago) – Posting: # 16355
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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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