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RegisterReplicate Study design for Brazil [Regulatives / Guidelines]
Dear All,
Brazil submission: Thus any body have any idea on Acceptance off Bio equivalence studies conducted in Replicate study design by ANVISA (Brazil). If acceptable what is the acceptance criteria to be followed (USFDA/Europe Approach).
Regards
Kotu
Edit: No need to post identical text twice within three days. The other post deleted (see the Forum’s Policy). [Helmut]
Brazil submission: Thus any body have any idea on Acceptance off Bio equivalence studies conducted in Replicate study design by ANVISA (Brazil). If acceptable what is the acceptance criteria to be followed (USFDA/Europe Approach).
Regards
Kotu
Edit: No need to post identical text twice within three days. The other post deleted (see the Forum’s Policy). [Helmut]
Complete thread:
- Replicate Study design for Brazilbalakotu 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 Brazil weidson 2018-05-22 20:51
Ing. Helmut Schütz