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Replicate Study design for Brazil [Regulatives / Guidelines]

posted by Weidson – Brazil, 2018-05-22 22:51 (2461 d 12:33 ago) – Posting: # 18799
Views: 2,755

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]

Complete thread:

Replicate Study design for Brazil balakotu 2018-05-21 13:31 [Regulatives / Guidelines]
- ABEL acc. to WHO Helmut 2018-05-21 16:47
- Replicate Study design for BrazilWeidson 2018-05-22 20:51

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