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RegisterMexico BE – add-on design? [Regulatives / Guidelines]
Hi Risherd!
Nice to meet you, even if it's only on the virtual level!
Good to know that I'm not alone searching for the modified release guidance.
Even better to know that the guidance is a law (must be a law, I guess, otherwise no way to demand performing BE trials inside Mexico), I had some guys wanting to change the model for ANOVA, gives me even more arguments for sticking to the approach given in the guideline.
In general the Mexican guidance is straight forward regarding various topics, but this add-on gives me some headaches. Do you have any experience on that? Does it have to be proposed in the initial protocol? Guess: yes, otherwise no way to preserve the consumer risk. Which statistics are accepted to keep the consumers risk at 5%?
Would be very interesting to know!
Best regards (rain, 9°C, brrrrr...)
nobody
Nice to meet you, even if it's only on the virtual level!
Good to know that I'm not alone searching for the modified release guidance.
Even better to know that the guidance is a law (must be a law, I guess, otherwise no way to demand performing BE trials inside Mexico), I had some guys wanting to change the model for ANOVA, gives me even more arguments for sticking to the approach given in the guideline.
In general the Mexican guidance is straight forward regarding various topics, but this add-on gives me some headaches. Do you have any experience on that? Does it have to be proposed in the initial protocol? Guess: yes, otherwise no way to preserve the consumer risk. Which statistics are accepted to keep the consumers risk at 5%?
Would be very interesting to know!
Best regards (rain, 9°C, brrrrr...)
nobody
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- Mexico BE – add-on design? nobody 2014-10-15 15:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Mexico BE – add-on design? Helmut 2014-10-15 15:50
- Mexico BE – add-on design? nobody 2014-10-15 16:47
- Rant Helmut 2014-10-15 17:38
- Rant nobody 2014-10-15 18:26
- Mexico BE – add-on design? nobody 2014-10-16 10:22
- Mexico BE – add-on design? Risherd 2014-10-24 00:26
- Mexico BE – add-on design? Helmut 2014-10-24 00:59
- Mexico BE – add-on design?nobody 2014-10-24 08:46
- Mexico BE – add-on design? Helmut 2014-10-24 19:05
- Mexico BE – add-on design? xtianbadillo 2016-04-07 18:54
- Mexico BE – add-on design? Mahesh M 2016-04-11 09:42
- No English translation Helmut 2016-04-11 13:29
- Mexico BE – add-on design? Mahesh M 2016-04-11 09:42
- Mexico BE – add-on design? Risherd 2014-10-24 00:26
- Rant Helmut 2014-10-15 17:38
- Mexico BE – add-on design? nobody 2014-10-15 16:47
- Mexico BE – add-on design? Helmut 2014-10-15 15:50
Ing. Helmut Schütz