Bioequivalence and Bioavailability Forum • Mexico BE – add-on design?

Mexico BE – add-on design? [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-10-15 17:50 (3920 d 03:48 ago) – Posting: # 13716
Views: 9,107

Ὀδυσσεύς

❝ Isn't that a "follow-up"-two-stage design or did I get something wrong here? Under 8.5.1.1 it states that type I error must be below 5%?!?,

That’s wacky. A combination of the old Canadian guidance with the current Japanese + decision based on power?

❝ .%%66#**?

Perfect description. See this thread and start to simulate.

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Complete thread:

Mexico BE – add-on design? nobody 2014-10-15 15:38 [Regulatives / Guidelines]
- Mexico BE – add-on design?Helmut 2014-10-15 15:50
  - Mexico BE – add-on design? nobody 2014-10-15 16:47
    - Rant Helmut 2014-10-15 17:38
      - Rant nobody 2014-10-15 18:26
    - Mexico BE – add-on design? nobody 2014-10-16 10:22
      - Mexico BE – add-on design? Risherd 2014-10-24 00:26
        
        Mexico BE – add-on design? Helmut 2014-10-24 00:59
        Mexico BE – add-on design? nobody 2014-10-24 08:46
        
        Mexico BE – add-on design? Helmut 2014-10-24 19:05
        Mexico BE – add-on design? xtianbadillo 2016-04-07 18:54
        
        Mexico BE – add-on design? Mahesh M 2016-04-11 09:42
        
        No English translation Helmut 2016-04-11 13:29

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