Bioequivalence and Bioavailability Forum

No idea [Surveys]

posted by Helmut  – Vienna, Austria, 2011-07-28 19:03 (5037 d 15:35 ago) – Posting: # 7236
Views: 10,390

Hi ElMaestro!

❝ I would do an audit.

Me too.

❝ Clearly some practice is bad here but it has to be said that there might not be a QA issue involved. Does the CRO have 100% QC, and if yes, how did the QC people get around this one?

No idea (as I said: big CRO).
Actually I got this issue like the virgin a child. I was asked by the sponsor for support in design­ing another study (see above). I wanted to run a PopPK model and play around with different sampling schedules – and, hocus-pocus! – the rabbit jumped out of the hat.*

I forwarded a lot of stuff to the (very, very big) sponsor and they are definitely not amused.

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• Rabbit = λ_z, hat = report.

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


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Science Quotes

Complete thread:

• Puzzle: Estimation of half life Helmut 2011-07-26 16:03 
  • Puzzle: Estimation of half life ElMaestro 2011-07-27 10:58
    • Puzzle: Estimation of half life Helmut 2011-07-27 15:10
  • Puzzle: Estimation of half life d_labes 2011-07-28 08:44
    • Puzzle: Estimation of half life Helmut 2011-07-28 11:38
  • Puzzle: Estimation of half life ElMaestro 2011-07-28 10:24
    • Puzzle: Estimation of half life Helmut 2011-07-28 11:53
      • 100% QC? ElMaestro 2011-07-28 16:38
        • No ideaHelmut 2011-07-28 17:03