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

posted by nobody – 2020-02-12 09:49 (1560 d 02:24 ago) – Posting: # 21163
Views: 6,600

❝ ❝ 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:

Same reaction here last night, but I thought I'm hallucinating due to ovewr-day fasting.

Kindest regards, nobody

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