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Registerpower of bioequivalence test [Power / Sample Size]
Tuesday October 26, 2010:
Concept of power of bioequivalence study troubles me.
The BE test of the pharmacokinetic parameters (Cmax and AUC) should be powered to be 0.8. Now, if after completing a BE data analysis, assume the parameter passes since it falls within the confidence intervals of 0.8-1.25. If at that point the power is calculated and the value is 0.5 does it mean "you got lucky" but "do not try it again".
Another point is if the parameter fails the BE test by being outside the confidence intervals for test v reference then you calculate the power. Will the value be low say ~0.4. or can the power of the test on this parameter failing BE still be 0.8 or above?
Please can someone me through this?
Angus
Edit: Category changed. [Helmut]
Concept of power of bioequivalence study troubles me.
The BE test of the pharmacokinetic parameters (Cmax and AUC) should be powered to be 0.8. Now, if after completing a BE data analysis, assume the parameter passes since it falls within the confidence intervals of 0.8-1.25. If at that point the power is calculated and the value is 0.5 does it mean "you got lucky" but "do not try it again".
Another point is if the parameter fails the BE test by being outside the confidence intervals for test v reference then you calculate the power. Will the value be low say ~0.4. or can the power of the test on this parameter failing BE still be 0.8 or above?
Please can someone me through this?
Angus
Edit: Category changed. [Helmut]
Complete thread:
- power of bioequivalence testAngusMcLean 2010-10-27 03:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Post-hoc power myth d_labes 2010-10-27 11:00
- Post-hoc power myth yjlee168 2010-10-27 12:06
- power of bioequivalence test ElMaestro 2010-10-27 11:41
- Post-hoc power myth d_labes 2010-10-27 11:00
Ing. Helmut Schütz