Bioequivalence and Bioavailability Forum • Several group design with unequal washout

Several group design with unequal washout [Design Issues]

posted by Helmut – Vienna, Austria, 2012-05-08 15:40 (5150 d 21:11 ago) – Posting: # 8532
Views: 6,915

Dear Sarawut!

❝ […] the washout intervals were not identical (not the same in each subject but at least 7 days) (also I think by subject's convenience).

Personally I have seen a maximum of three groups – but I know that more have been used, especially for HVDs in the ages before scaling (sample sizes >100). Unequal washouts (let’s say 8 and 10 days if the protocol specified at least 7 days) are not that uncommon (e.g., if one of the treatment days would be a public holiday). Never heard about any problems with regulators.

❝ It is a standard 2x2x2 BE design for a total of 44 subjects with balanced arm.

❝ Do you think it is acceptable if the test of group effect is not significant.

❝ Also is it possible to test group effect in this study (5 groups)?

Three questions. Answers: yes, yes, and why not?

See also this post including a reference.

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Complete thread:

Several group design with unequal washout sarawut 2012-05-08 12:36 [Design Issues]
- Several group design with unequal washoutHelmut 2012-05-08 13:40
  - Hidden Q? d_labes 2012-05-08 15:02
    - Q unveiled Helmut 2012-05-08 15:38
      - Q or not Q ? Ohlbe 2012-05-09 11:15
        
        "." ≠ "?" Helmut 2012-05-09 12:28
  - Several group design with unequal washout sarawut 2012-05-08 16:49
    - Several group design with unequal washout boonchai_l 2012-05-16 12:19
      - Thai FDA Helmut 2012-05-16 13:01
        
        Thai FDA boonchai_l 2012-05-16 13:37
        
        Thai FDA Helmut 2012-05-16 13:55
        
        Thai FDA boonchai_l 2012-05-16 19:02
        
        Thai FDA ElMaestro 2012-05-21 23:45
        
        Thai FDA boonchai_l 2012-05-21 12:05
- Several group design with unequal washout sarawut 2012-06-05 06:02