Winter is coming to EEU [Regulatives / Guidelines]
Dear Yura,
as you probably know, Belarus is a member of Eurasian Economic Union.
I don't know did the rules of medicines circulation come into force in Belarus or not, but I would suggest to use it. As far as I know the BEQ guideline for EEU was developed by experts in Belarus.
So you can download it here and open the page 44 (47 Adobe speaking).
The point 94 says that the BEQ study conducted in different sites are suspicious (sic!) and you need to discuss the design with expert first.
I'm also wondering regarding the sentence in the previous point of Guideline:
'Especially during the model building it should be taken into account the fact that periods of 1st group are not the same as periods of the second'
Hmmm... Does that mean that we need to add Period*Group statement?
Let's see our Guru's opinion!
as you probably know, Belarus is a member of Eurasian Economic Union.
I don't know did the rules of medicines circulation come into force in Belarus or not, but I would suggest to use it. As far as I know the BEQ guideline for EEU was developed by experts in Belarus.
So you can download it here and open the page 44 (47 Adobe speaking).
The point 94 says that the BEQ study conducted in different sites are suspicious (sic!) and you need to discuss the design with expert first.
I'm also wondering regarding the sentence in the previous point of Guideline:
'Especially during the model building it should be taken into account the fact that periods of 1st group are not the same as periods of the second'
Hmmm... Does that mean that we need to add Period*Group statement?
Let's see our Guru's opinion!
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- multicenter crossover bioequivalent study Yura 2016-08-29 08:10 [Regulatives / Guidelines]
- ICH E9 has the answer DavidManteigas 2016-08-29 13:55
- please explain your opinion regarding ICH E9 mittyri 2016-08-29 15:12
- please explain your opinion regarding ICH E9 DavidManteigas 2016-09-01 13:47
- ICH E9 has the answer Yura 2016-08-29 15:16
- ICH E9 has the answer BE-proff 2016-08-30 08:31
- please explain your opinion regarding ICH E9 mittyri 2016-08-29 15:12
- Winter is coming to EEUmittyri 2016-08-29 15:03
- ICH E9 has the answer DavidManteigas 2016-08-29 13:55