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

posted by Helmut Homepage – Vienna, Austria, 2020-02-12 13:12  – Posting: # 21164
Views: 1,158

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

Cheers,
Helmut Schütz
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