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RegisterEMA: Two-Stage design [Two-Stage / GS Designs]
Hi colleagues,
The EMEA guideline states that it is acceptable to use a two-stage approach when attempting to demonstrate bioequivalence. Can anyone enlighten me on this kind of study design, steps to be taken, stopping criteria or can we automatically switch to stage 2 if the BE fails at stage 1? Thanks and regards.
Edit: Category changed. [Helmut]
The EMEA guideline states that it is acceptable to use a two-stage approach when attempting to demonstrate bioequivalence. Can anyone enlighten me on this kind of study design, steps to be taken, stopping criteria or can we automatically switch to stage 2 if the BE fails at stage 1? Thanks and regards.
Edit: Category changed. [Helmut]
Complete thread:
- EMA: Two-Stage designjoyjac 2011-07-05 07:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: Two-Stage design Helmut 2011-07-05 19:38
Ing. Helmut Schütz