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

posted by ElMaestro  – Denmark, 2020-02-12 09:27 (1090 d 19:53 ago) – Posting: # 21162
Views: 5,190

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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