analysis of predose concentration [General Sta­tis­tics]

posted by yuvrajkatkar – Pune, Maharashtra (India), 2010-02-17 11:03 (5967 d 02:06 ago) – Posting: # 4777
Views: 3,043

Dear Sir,

Bioanalytical designee tell that NR (Not Reportable) predose concentration value is greater than 5% of Cmax, Due to some reason we reported it as NR.

Can, I exclude that subjects from pharmacokinetic and statistical analysis?.

I know that emea guideline told that, if predose concentration value is greater than 5% of Cmax exclude that subject from pharmacokinetic and statistical analysis.

I need your guidance.
—
Best Regards,
Yuvraj

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