Bioequivalence and Bioavailability Forum • Pseudo-periods

Pseudo-periods [Design Issues]

posted by Helmut – Vienna, Austria, 2019-03-15 01:47 (1863 d 08:08 ago) – Posting: # 20037
Views: 19,386

Hi ElAlumno (nice nick!),

❝ In your old but still-useful post (excerpt below), you describe generating pseudo-sequences and pseudo-periods when assessing ABE.

❝

❝ ❝ A 6×3 design is needed in order to ‘extract’ two 2×2 tables, [ :blahblah: ]

❝

❝ Your post preceded the EMA's Guideline on the Investigation of Bioequivalence by a few years, but it appears to agree with their stipulation: […]

Not quite.

❝ I completely understand the use of pseudo-sequences in this situation. But what about pseudo-periods? The EMA guidelines aren't too specific.

The EMA means the ‘Two‐at‐a‐Time Principle’ (see above) and not my recoding (which I abandoned a good while ago as well).
David Brown (MHRA, member the EMA’s Biostatistics Working Party) gave a clarification at the 3^rd EGA Symposium on Bioequivalence (London, June 2010). The Q&A document states:

However, the treatment, groups, sequences and periods should have their original values maintained in the analysis, and not have the values modified. For example an observation made in period 3 should still be coded as period 3, not have the period changed to “2” because the results for that subject in one of the earlier periods has now be removed.

(my emphasis)

❝ On the one hand, if you wish to display your data with pseudo-sequences, you would want to use pseudo-periods too …

Nope. Relevant slides:

[image] Guideline
[image] Question
[image] Question
[image] Answer
[image] Answer

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Complete thread:

Three-way crossover BABE Studies acfalcao 2007-09-16 22:34 [Design Issues]
- Three-way crossover example data set Helmut 2007-09-17 20:47
  - Three-way crossover example data set acfalcao 2007-09-17 23:02
    - Three-way crossover example data set Helmut 2007-09-18 12:47
      - Three-way crossover (WinNonlin) Nirali 2007-09-21 06:49
        
        Three-way crossover (WinNonlin) Helmut 2007-09-21 13:04
        
        Three-way crossover (WinNonlin) Nirali 2007-09-25 08:05
        
        Three-way crossover (WinNonlin) Helmut 2007-09-25 13:15
      - Three-way crossover example data set Irene_I 2018-06-07 11:09
        
        Three-way crossover example data set Helmut 2018-06-07 13:04
        
        Three-way crossover example data set Irene_I 2018-06-08 11:09
        Three-way crossover example data set Irene_I 2018-06-12 09:21
        
        Leave-One-Out (IBD) Helmut 2018-06-12 12:42
        
        Leave-One-Out (IBD) Irene_I 2018-06-13 05:02
        
        Impact of pooled variance (bias, CI) Helmut 2018-06-13 15:02
        
        carry (over?) d_labes 2018-06-13 15:31
  - Pseudo-periods ElAlumno 2019-03-14 23:40
    - Pseudo-periodsHelmut 2019-03-15 00:47
      - Two‐at‐a‐Time analysis in R ElAlumno 2019-03-22 21:59
        
        fixed & mixed (dammit!) and a request to SASians Helmut 2019-03-23 01:03
        
        Pooled vs IBD T-R in SAS from non-SASian mittyri 2019-03-23 23:13
        
        Pooled vs IBD T-R in SAS from non-SASian Helmut 2019-03-23 23:36
        
        mixed in R mittyri 2019-03-23 23:50
        
        mixed in R (EMA B ≠ FDA) Helmut 2019-03-24 01:23
  - Williams design 3-way Brus 2021-06-09 16:48
    - Williams design 3-way Helmut 2021-06-09 17:48
      - Williams design 3-way Brus 2021-06-10 14:33
        
        Williams design 3-way Helmut 2021-06-10 15:03
        
        Williams design 3-way vezz 2021-06-10 17:23
        
        Williams design 3-way Helmut 2021-06-10 20:14
        
        Williams design 3-way vezz 2021-06-11 09:11
        
        Williams design 3-way Brus 2021-06-11 12:19
        Williams design 3-way Relaxation 2021-06-11 12:42
        
        Period effects in general Helmut 2021-06-11 15:41
        Williams design 3-way vezz 2021-06-11 16:56