Bioequivalence and Bioavailability Forum • TRT / RTR Design

TRT / RTR Design [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2017-05-06 20:33 (3338 d 23:07 ago) – Posting: # 17312
Views: 12,109

Hi ElMaestro & Yura,

❝ But having said that I think the sentence is OK, only the meaning is a bit out of context.

Right. It appears in the introduction about the FDA’s RSABE. Nothing like that in the next paragraph about the EMA’s ABEL. The GL states only the periods (three or four) and no specific designs/sequences. In the Q&A the RTRT|TRTR and the RRT|RTR|TRR are given as examples. In Rev. 12 of the Q&A the TRT|RTR is discussed (requiring at least 12 subject in sequence RTR).

❝ Blumentopferde :cool:

Love it!

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Helmut Schütz

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Complete thread:

TRT / RTR Design Yura 2017-05-01 09:34
- TRT / RTR Design mittyri 2017-05-02 18:38
  - TRT / RTR Design Yura 2017-05-02 21:19
    - TRT / RTR Design Helmut 2017-05-02 22:04
      - TRT / RTR Design Yura 2017-05-03 07:41
        
        TRT / RTR Design Helmut 2017-05-03 21:49
        
        TRT / RTR Design ElMaestro 2017-05-03 22:04
        
        TRT / RTR DesignHelmut 2017-05-06 18:33
        
        TRR / RTT Design Yura 2017-05-09 11:35
        
        TRR / RTT Design Helmut 2017-05-09 13:06
        
        TRR / RTT Design Yura 2017-05-09 16:18
        
        TRR / RTT Design Helmut 2017-05-09 16:56
        
        TRR / RTT Design Yura 2017-05-09 17:36
        
        TRR / RTT Design Helmut 2017-05-09 17:53
        
        TRR / RTT Design Yura 2017-05-09 18:07