Bioequivalence and Bioavailability Forum • Mexico BE

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

posted by nobody – 2014-10-15 17:38 (4271 d 06:31 ago) – Posting: # 13715
Views: 11,592

Hi again!

There is a BE-guidance for Mexico dated 2013

http://www.dof.gob.mx/nota_detalle_popup.php?codigo=5314833

...apparently only in Spanish.

It states under 8.5.3 that, if no bioequivalence has been shown in the study and power is <80% an "add-on" study with additional subjects can be performed, number of individuals to be added should be calculated based on the intraindividual CV (is what I would translate).

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%?!?,.%%66#**?

—
Kindest regards, nobody

Complete thread:

Mexico BE – add-on design?nobody 2014-10-15 15:38
- 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