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RegisterSOPitis [Design Issues]
Hi ElMaestro & all!
Could you give an example of wording?
"Multicentre, single-dose, randomised, open label, two-sequence, two-period, crossover, bioavailability study in male and female patients under fed conditions with gender stratification" - something like that?
Would stratification be applicable in BEQ studies from assessors point of view? Any experience?
❝ I think I would word the protocol and study title carefully. The study is not really randomised if some randomisations are better than others. This is when I think stratification must be part of the wording.
Could you give an example of wording?
"Multicentre, single-dose, randomised, open label, two-sequence, two-period, crossover, bioavailability study in male and female patients under fed conditions with gender stratification" - something like that?
Would stratification be applicable in BEQ studies from assessors point of view? Any experience?
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Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Randomization procedure with gender stratification Silva 2014-02-26 12:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- If possible, yes. Helmut 2014-02-26 13:34
- If possible, yes. Silva 2014-02-26 13:41
- Trial and error Helmut 2014-02-26 13:53
- Trial and error Silva 2014-02-26 14:05
- Trial and error ElMaestro 2014-02-26 14:45
- Trial and error Helmut 2014-02-26 13:53
- If possible, yes. Silva 2014-02-26 13:41
- If possible, yes. Helmut 2014-02-26 13:34
Ing. Helmut Schütz