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RegisterBE criteria for Parallel design with large CV [Design Issues]
Dear BK Park.
If you have to use a parallel group design you will not be able to claim widened acceptance ranges for BE, sorry
. In order to minimize the risk to fail the study and to adjust the sample size (important for a highly variable drug) I suggest to use an adaptive parallel design. So you start your study with an in-study pilot part and after an interim analysis you can (hopefully) predict the outcome and adjust the sample size.
Kind regards
Dan
❝ Could you please let me know the way to expand BE criterion for parallel
❝ design?
If you have to use a parallel group design you will not be able to claim widened acceptance ranges for BE, sorry
. In order to minimize the risk to fail the study and to adjust the sample size (important for a highly variable drug) I suggest to use an adaptive parallel design. So you start your study with an in-study pilot part and after an interim analysis you can (hopefully) predict the outcome and adjust the sample size.Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- BE criteria for Parallel design with large CV cats99 2011-02-13 09:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE criteria for Parallel design with large CVDr_Dan 2011-02-16 11:10
- BE criteria for Parallel design with large CV Dr RCG 2011-04-06 05:24
Ing. Helmut Schütz