Pseudo-periods [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2019-03-14 23:47 (625 d 01:23 ago) – Posting: # 20037
Views: 8,718

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 3rd 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] GL
[image] Q
[image] Q
[image] A
[image] A

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Helmut Schütz

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