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RegisterBlinding in Canadian BE Study [Regulatives / Guidelines]
Hi,
I ran a study for Canadian submission before and it was single blinded. However, my company has submitted US open-label BE studies and the studies were accepted by TPD (Canada). Yes the studies used Canadian reference products but were FDA open-label study design.
John
I ran a study for Canadian submission before and it was single blinded. However, my company has submitted US open-label BE studies and the studies were accepted by TPD (Canada). Yes the studies used Canadian reference products but were FDA open-label study design.
John
Complete thread:
- Blinding in Canadian BE Study pravin17 2012-05-09 09:07 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Blinding in Canadian BE Study drgunasakaran1 2012-05-09 11:21
- Blinding in Canadian BE Study akinapally 2012-05-09 12:23
- Blinding in Canadian BE Studyjag009 2012-05-10 15:11
- Blinding in Canadian BE Study akinapally 2012-05-11 06:16
Ing. Helmut Schütz