Log in
RegisterANVISA - SABE [Design Issues]
Hi Luvblooms
True.. that is the reason I have mentioned to submit a protocol with replicated design for ANVISA review before initiating a study.
During ANVISA review, the agency had asked us to follow EU guidance for widening. (so I assume widening would be applicable to Cmax only).
Not sure!
Regards,
Samaya
❝ You just got lucky!!!! That's all I will say as per my interaction with ANVISA. They are tough nut to crack!!
True.. that is the reason I have mentioned to submit a protocol with replicated design for ANVISA review before initiating a study.
❝ Does this mean that widening given only for Cmax and max limit will be 69-143?
During ANVISA review, the agency had asked us to follow EU guidance for widening. (so I assume widening would be applicable to Cmax only).
❝ Any specific reason behind it?
Not sure!
Regards,
Samaya
Complete thread:
- ANVISA - SABE msmnainar 2015-04-27 09:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA - SABE nobody 2015-04-27 09:15
- ANVISA - SABE Samaya B 2015-04-27 10:03
- ANVISA - SABE luvblooms 2015-04-27 11:34
- ANVISA - SABESamaya B 2015-04-27 12:03
- ANVISA - SABE felipeberlinski 2015-04-27 15:36
- ANVISA - SABE msmnainar 2015-04-28 13:11
- ANVISA - SABE felipeberlinski 2015-04-27 15:36
- ANVISA - SABESamaya B 2015-04-27 12:03
- ANVISA - SABE luvblooms 2015-04-27 11:34
Ing. Helmut Schütz