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

posted by Beholder  – Russia, 2016-05-23 18:23 (3334 d 20:13 ago) – Posting: # 16354
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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]
—
Best regards
Beholder

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