I wouldn’t do that [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2014-02-06 03:35 (3780 d 06:02 ago) – Posting: # 12352
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Hi Mittyri,

❝ Could you explain your practice and guideline interpretation:


I don’t base my decisions primarily on guidelines. ;-) You never know why a subject drops out. What if vomiting was drug-related or even a SUSAR? The sponsor has the budget to analyse all samples, so do it – as far as they are available. Some background:
PS: EMA’s GL is ambiguous: “Drop-out and withdrawal of subjects should be fully documented. If available, concentration data and pharmacokinetic parameters from such subjects should be presented in the individual listings, but should not be included in the summary statistics.”
I would say: Make them available.

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