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RegisterDon’t Over Power [Power / Sample Size]
Dear Byung-Ju, dear Helmut
the advantage of overpowering a study (seen from the company perspective) is that you get very narrow 90% confidence intervals. So if you have a formulation which is borderline bioequivalent (for example if your point estimator is round about 85% or 120%) you can get results within the acceptance range if you include much more subjects than needed according to the intra subject variability of the drug. There is a certain risk that the regulatory authority could refuse a marketing authorisation because only by overpowering the study became acceptable.
Kind regards
Dan
the advantage of overpowering a study (seen from the company perspective) is that you get very narrow 90% confidence intervals. So if you have a formulation which is borderline bioequivalent (for example if your point estimator is round about 85% or 120%) you can get results within the acceptance range if you include much more subjects than needed according to the intra subject variability of the drug. There is a certain risk that the regulatory authority could refuse a marketing authorisation because only by overpowering the study became acceptable.
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:
- Bioequivalence of Sample Size (Over Power) bjkim97 2011-02-08 17:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Don’t Over Power Helmut 2011-02-08 20:30
- Don’t Over PowerDr_Dan 2011-02-09 09:31
- Expected deviation Helmut 2011-02-09 11:10
- Don't Over Power bjkim97 2011-02-09 17:28
- Don’t Over PowerDr_Dan 2011-02-09 09:31
- Don’t Over Power Helmut 2011-02-08 20:30
Ing. Helmut Schütz