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RegisterReplicate Design [Two-Stage / GS Designs]
Hello Naveen,
Yes, that should be a possibility but:
Not understood - can you explain what you mean?
❝ Please suggest, can we design full replicate bioequivalence study (molecule is highly variable) in stages for EMEA submission.
Yes, that should be a possibility but:
- There are no publications about two-stage BE trials combined with replicated designs. You might be asked to prove by your own simulations that type I errors are controlled at max 5% or so.
- Don't do it without a meeting with FDA.
❝ My concern is Power will play pivotal role in stage design, which not be in replicate (full) designs.
Not understood - can you explain what you mean?
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Replicate Design Naveen Kumar 2014-06-23 13:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Replicate DesignElMaestro 2014-06-23 13:32
- Science fiction Helmut 2014-06-23 14:53
- Science fiction Naveen Kumar 2014-06-28 07:26
- Interim analysis? Helmut 2014-06-28 12:09
- Science fiction Naveen Kumar 2014-06-28 07:26
- Science fiction Helmut 2014-06-23 14:53
- Replicate DesignElMaestro 2014-06-23 13:32
Ing. Helmut Schütz