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RegisterExpected deviation in sample size calculation [Power / Sample Size]
Dear Skar
What do you mean by "expected deviation"? True difference in formulation (µT/µR) or difference in number of subjects needed to demonstrate BE with a specific power and number of enrolled subjects (drop out reserve)? In both cases the answer is: it depends....
In general you calculate your sample size with a formulation difference < 5%. Assuming a greater difference will tell an assessor that you have information showing that your formulation is borderline bioequivalent (= bad formulation that can only fit in the BE acceptance range if the study is overpowered).
To calculate the drop out reserve you need to know the adverse event profile of the drug and the compliance of the subjects.
I hope this helps.
Kind regards
Dan
What do you mean by "expected deviation"? True difference in formulation (µT/µR) or difference in number of subjects needed to demonstrate BE with a specific power and number of enrolled subjects (drop out reserve)? In both cases the answer is: it depends....
In general you calculate your sample size with a formulation difference < 5%. Assuming a greater difference will tell an assessor that you have information showing that your formulation is borderline bioequivalent (= bad formulation that can only fit in the BE acceptance range if the study is overpowered).
To calculate the drop out reserve you need to know the adverse event profile of the drug and the compliance of the subjects.
I hope this helps.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Expected deviation in sample size calculation Karmegams 2011-06-10 07:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Expected deviation in sample size calculationDr_Dan 2011-06-10 08:51
- Expected deviation in sample size calculation Karmegams 2011-06-10 09:57
- Expected deviation in sample size calculation ElMaestro 2011-06-10 12:19
- Expected deviation in sample size estimation Helmut 2011-06-10 13:40
- Expected deviation in sample size estimation Dr_Dan 2011-06-10 15:06
- Expected deviation in sample size estimation Karmegams 2011-06-13 06:05
- Expected deviation in sample size estimation GSTATS 2011-06-13 07:36
- Expected deviation in sample size estimation Helmut 2011-06-10 13:40
- Expected deviation in sample size calculationDr_Dan 2011-06-10 08:51
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