Bioequivalence and Bioavailability Forum

Missing values [Study Per­for­mance]

posted by d_labes  – Berlin, Germany, 2008-07-30 15:39 (6126 d 13:02 ago) – Posting: # 2103
Views: 16,755

Dear Martin

❝ ...

❝ for PK analyses, both data sets are analyzed and the results for the full analyses data set is the more important as pointed out by the ICH E9 guideline ...

                                                     ^^^^^^


Just to quote ICH E9 paragraph 3.3.2 Trials to Show Equivalence or Non-inferiority:

"... The equivalence (or non-inferiority) trial is not conservative in nature, so that many flaws in the design or conduct of the trial will tend to bias the results towards a conclusion of equivalence. For these reasons, the design features of such trials should receive special attention and their conduct needs special care ..."

IMHO this calls for the per protocol analysis as the primary one.
Best would be if you have only per protocol volunteers/subjects.

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 values Helmut 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 valuesd_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