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

posted by ElMaestro  – Belgium?, 2020-02-12 08:27 (295 d 05:40 ago) – Posting: # 21162
Views: 3,344

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:

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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