Bioequivalence and Bioavailability Forum

Missing values [Study Per­for­mance]

posted by Helmut  – Vienna, Austria, 2008-07-30 00:18 (6127 d 02:25 ago) – Posting: # 2098
Views: 17,049

Dear Martin!

❝ according to my point of view you have to define of a full analysis data set (FADS) and a per-protocol analysis data set (PADS) according to ICH E9.

❝ for FADS you have to analyze the data as they are whereas for the PADS you can specify exclusion/inclusion criteria […]

To quote ICH E9 (Section 5.3):

“If no procedure for dealing with outliers was foreseen in the trial protocol, one analysis with the actual values and at least one other analysis eliminating or reducing the outlier effect should be performed and differences between their results discussed.” (my emphasis in blue)

Reading the Q&A document quoted by ElMaestro in his post again I’m getting the impression members of the CHMP/PK group don’t (want to?) know this guideline…

If I anticipated events and stated a decision-tree in the protocol, there’s no need to come up with two bloody evaluations.
To quote from the movíe ‘Highlander’:

There can be only one!

What's the full data set if a subject comes up with a zero response after the reference formulation?
Is T/R of this subject ‘infinity’ or only ‘undefined’? Ask a mathematician.
My kind of software simply cannot deal with such a value…

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


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Science Quotes

Complete thread:

• Missing values ratnakar1811 2008-04-02 14:07 [Study Per­for­mance] 
  • Missing values Helmut 2008-04-02 14:54
    • Missing values atish_azad 2008-07-29 11:03
      • Missing values ElMaestro 2008-07-29 11:21
        • Missing values Helmut 2008-07-29 21:40
          • Missing values ElMaestro 2008-07-31 10:38
            • Missing values Helmut 2008-07-31 14:36
      • Missing values Helmut 2008-07-29 21:18
  • Missing values martin 2008-07-29 13:56
    • Missing valuesHelmut 2008-07-29 22:18
      • Missing values martin 2008-07-30 10:28
        • ITT vs. PP data sets Helmut 2008-07-30 13:30
        • Missing values d_labes 2008-07-30 13:39
          • Missing values Helmut 2008-07-30 14:34
          • Missing values martin 2008-07-30 14:50
            • Missing values Helmut 2008-07-30 17:14
              • Missing values d_labes 2008-07-31 09:18