Bioequivalence and Bioavailability Forum

I wouldn’t do that [Outliers]

posted by Helmut  – Vienna, Austria, 2014-02-06 03:35 (3333 d 20:12 ago) – Posting: # 12352
Views: 8,509

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:

• The end of this post.
  
• #8346
  
• #4997

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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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Outlier in a BE study auditor 2013-11-14 10:38 
  • Outlier in a BE study Dr_Dan 2013-11-14 14:41
    • Outlier in a BE study Erkin 2014-01-21 19:21
      • Outliers: reasons to not analyse? mittyri 2014-01-30 20:14
        • I wouldn’t do thatHelmut 2014-02-06 02:35
  • Outlier in a BE study jag009 2013-11-15 22:06
  • Outlier in a BE study riteshsrmc 2014-01-16 12:44
    • Outlier in a BE study Helmut 2014-01-16 14:54
  • Outlier in a BE study luvblooms 2014-01-27 09:11