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RegisterReplicate Study design for Brazil [Regulatives / Guidelines]
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]
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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ABEL acc. to WHO Helmut 2018-05-21 16:47
- Replicate Study design for BrazilWeidson 2018-05-22 20:51
Ing. Helmut Schütz