ANVISA guidelines for two-stage design [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2020-02-12 08:27 (459 d 14:01 ago) – Posting: # 21162
Views: 3,992

Hi MS,

» Art.75. For two-stage studies, the following should be noted: It is acceptable to use a two-stage approach to demonstrate bioequivalence based on ignorance of the intra-individual variability of the drug;


Ermmm...... WHAT???? :-D:party:

Pass or fail!
ElMaestro

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