Bioequivalence and Bioavailability Forum • Thai FDA

Thai FDA [Design Issues]

posted by Helmut – Vienna, Austria, 2012-05-16 15:01 (5139 d 15:22 ago) – Posting: # 8574
Views: 6,700

สวัสดี Boonchai!

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

Interesting. If the announcement is available online can you provide us the URL?

Resonable.
Hhm; that’s nitpicking. We plan studies in such a way that we don’t expect carry-over with the minimum washout stated in the protocol. Even if there is a small carry-over it would be even lower for subjects in the group(s) with longer washouts. BE is based on within-subject comparisons – so what?
I wouldn’t call that stupid but consistent. BTW, testing for a group effect is based on a between-subject comparison which has very low statistical power.

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Science Quotes

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 washout boonchai_l 2012-05-16 12:19
      - Thai FDAHelmut 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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