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

posted by nobody – 2014-10-15 17:38 (3452 d 14:12 ago) – Posting: # 13715
Views: 9,008

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

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