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RegisterBE trial design as partial replicate and two stage [Regulatives / Guidelines]
Hi Silva,
There are no publications about two-stage studies and replicated designs of any type. Therefore I would only attempt to do it after a scientific advice. They may ask you to prove by your own simulations if/how the method performs in various scenarios.
❝ Is it advisable to use two stage design approach in partial replicate design?
❝ If yes, which alpha level should be used for the second stage (combined stage I + stage II data)?
There are no publications about two-stage studies and replicated designs of any type. Therefore I would only attempt to do it after a scientific advice. They may ask you to prove by your own simulations if/how the method performs in various scenarios.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- BE trial design as partial replicate and two stage Silva 2014-04-17 08:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE trial design as partial replicate and two stageElMaestro 2014-04-17 09:17
- BE trial design as partial replicate and two stage Silva 2014-04-17 09:36
- EMA = PSRPH? Helmut 2014-04-17 15:33
- BE trial design as partial replicate and two stage Silva 2014-04-17 09:36
- BE trial design as partial replicate and two stageElMaestro 2014-04-17 09:17
Ing. Helmut Schütz