Bioequivalence and Bioavailability Forum • Common sense instead of statistics

Common sense instead of statistics [Software]

posted by Helmut – Vienna, Austria, 2020-04-27 13:45 (2229 d 06:04 ago) – Posting: # 21351
Views: 11,868

Hi vixen,

❝ I like Helmut's suggestion to assess achievement of SS for individual subjects.

My suggestion dates back to 2007. A while ago…
I don’t use it since 2010 and don’t recommend it any more (see this presentation, slide 14). Furthermore, the EMA stated:*

A specific statistical method to assure that steady state has been reached is not considered necessary in bioequivalence studies. Descriptive data is sufficient.

❝ I wonder though whether I should evaluate the Cpds on a normal or logarithmic scale.

Normal – otherwise you cannot deal with BQLs and missings.

❝ What is your approach?

See the presentation.

EMEA. Overview of Comments received on Draft Guideline on the Investigation of Bioequivalence. EMA/CHMP/EWP/26817/2010. London. 20 January 2010. Online.

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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 SS Helmut 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 statisticsHelmut 2020-04-27 11:45