Bioequivalence and Bioavailability Forum • Exclusion of subjects who are not in SS

Exclusion of subjects who are not in SS [Software]

posted by Helmut – Vienna, Austria, 2007-08-07 00:16 (6889 d 14:31 ago) – Posting: # 966
Views: 23,683

Dear Imran!

❝ In SS study Cpd Analysis should we calculate SS acheived for each subject, or it should be calulated as a mean of all observation.

As already told in this thread, my personal preferences are always to assess achievement of SS for individual subjects.

❝ What if a subject 'A' has not acheived SS, sholud the subject be included in the PK analysis.

IMHO this subject should be excluded, because if the subject was not in steady state, the superposition principle of pharmacokinetics is not fulfilled.
You may only make valid statements (about accumulation, etc.) if
AUCinf (single dose) = AUCtau (steady state).

❝ I understand we calculate ABE, but would be it questioned if any subject is not in SS state.

At least I would do so! :-D

—
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Helmut Schütz

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Complete thread:

Steady state calculation using WinNonlin Imran 2007-06-27 06:02
- Steady state calculation using WinNonlin Helmut 2007-06-27 11:56
  - Steady state calculation using WinNonlin Imran 2007-06-29 05:13
    - Please use the Preview! Jaime_R 2007-06-29 10:29
      - Please use the Preview! Imran 2007-06-30 12:50
        
        no attachments and uploads... Jaime_R 2007-06-30 13:33
    - Steady state calculation using WinNonlin Helmut 2007-06-29 21:08
      - Steady state calculation using WinNonlin Imran 2007-08-02 13:52
        
        Steady state calculation using WinNonlin Helmut 2007-08-02 15:07
        
        Steady state calculation using WinNonlin Imran 2007-08-06 11:48
        
        Exclusion of subjects who are not in SSHelmut 2007-08-06 22:16
        
        Exclusion of subjects who are not in SS KR 2009-04-13 14:34
        Exclusion of subjects who are not in SS vixen 2020-04-27 10:10
        
        Common sense instead of statistics Helmut 2020-04-27 11:45