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

posted by Helmut Homepage – Vienna, Austria, 2020-02-12 14:12 (1732 d 12:47 ago) – Posting: # 21164
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Hi ElMaestro,

❝ ❝ ignorance of the intra-individual variability of the drug;



❝ Ermmm...... WHAT???? :-D:party:


Lost in translation?

É aceitável usar uma abordagem de dois estágios para demonstrar a bioequivalência baseada nodesconhecimento da variabilidade do fármaco;


I have the same translation like Mauricio. Google-translate suggests ‘unknowing’ for ‘nodesconhecimento’ but if you feed the entire sentence, ‘ignorance’ shows up. :-D

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