Replicate Study design for Brazil [Regulatives / Guidelines]

posted by weidson – Brazil, 2018-05-22 18:51 (1064 d 01:54 ago) – Posting: # 18799
Views: 1,751

Dear balakotu

The ANVISA have adopted the EMA's Approach. However, for you use this approach you need to convince them that their drug is highly variable. I hope I have helped you.

Best Regards
Weidson C. de Souza

Edit: Post moved. [Helmut]

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