Bioequivalence and Bioavailability Forum • Several group design with unequal washout

Several group design with unequal washout [Design Issues]

posted by boonchai_l – Thailand, 2012-05-16 14:19 (5139 d 15:01 ago) – Posting: # 8573
Views: 6,791

SA-WAS-DEE Sarawut,

Let see announcement number สธ1009.4/ว.11243 from Thai FDA date 13 Sep 2011.

They stated (in Thai text) that the number of group should be minimized.
They also emphasized that all groups had to be the same washout period.
Moreover, they said the stupid statement that if group effect could be detected, the BE evaluation could not be pooled from those several groups (OMG).

I quite sure that the design you mentioned will be rejected from Thai FDA because of the announcement #2.

Accoulding to your question,

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

The answer is in #3.

Regards,
Boonchai_L

Complete thread:

Several group design with unequal washout sarawut 2012-05-08 12:36 [Design Issues]
- Several group design with unequal washout Helmut 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 washoutboonchai_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

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