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Registerunderstanding about power in bioequivalence [Power / Sample Size]
Hi Joystar
Power is the chance of showing bioequivalence under your own assumptions of product performance. It is therefore unrelated to patient's risk.
For this reason, there is no strict regulatory requirement about power. If it is too low (too few subjects) then the study may be futile. If the power is too high you may be including more subjects than necessary for the given purpose.
So, many companies select 80% - this is just an empirical choice based on a tradeoff between chance of success and risk of failure. 90% is also commonly used. 70% is in my opinion slightly more rare as it involves a failure risk of 30%.
❝ i have just joined this forum to learn pharmacokinetic and statistical analysis in Bio-equivalence. i read about power and errors in bioequivalence. i don't understand why the power is 80% not 90 or 70.
Power is the chance of showing bioequivalence under your own assumptions of product performance. It is therefore unrelated to patient's risk.
For this reason, there is no strict regulatory requirement about power. If it is too low (too few subjects) then the study may be futile. If the power is too high you may be including more subjects than necessary for the given purpose.
So, many companies select 80% - this is just an empirical choice based on a tradeoff between chance of success and risk of failure. 90% is also commonly used. 70% is in my opinion slightly more rare as it involves a failure risk of 30%.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- understanding about power in bioequivalence joystar 2012-09-27 12:11
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- understanding about power in bioequivalenceElMaestro 2012-09-27 12:41
- 80–90% power Helmut 2012-09-27 14:09
- 80–90% power jag009 2012-09-27 21:23
Ing. Helmut Schütz