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RegisterReported 99.98%, correct 1.4% [Power / Sample Size]
Hi mreyes,
I think I got your question. It is often safe enough to assume the CV from another trial when you believe you can match the conditions, but of course you should not make assumptions about your (true) GMR on basis of a literature reference.
Therefore, I would do a dissolution trial or whatever you have available and judge the GMR from it, and secondly I would make an assumption about the CV from a published document, regardless of whether that document involved a failed trial or a successful one. Of course if you have concern about the validity of the reported CV then don't use it.
Hi Hötzi,
Completely correct. Crap is the proper diplomatic term. They used GMR=1.00 and the observed CV for their calculation of post-hoc power. Therefore I don't know what the figure means and I am not aware of any reasonable use of such a figure.
Common sense seems to be in short supply these days.
I think I got your question. It is often safe enough to assume the CV from another trial when you believe you can match the conditions, but of course you should not make assumptions about your (true) GMR on basis of a literature reference.
Therefore, I would do a dissolution trial or whatever you have available and judge the GMR from it, and secondly I would make an assumption about the CV from a published document, regardless of whether that document involved a failed trial or a successful one. Of course if you have concern about the validity of the reported CV then don't use it.
Hi Hötzi,
❝ Excuse my French, but this synopsis is crap. The CV for free ezetimibe’s AUC0-t is 20.5% (assuming 25/24 subjects in the sequences). Bloody irrelevant post hoc power is ~1.4% – not 99.98%!
Completely correct. Crap is the proper diplomatic term. They used GMR=1.00 and the observed CV for their calculation of post-hoc power. Therefore I don't know what the figure means and I am not aware of any reasonable use of such a figure.
Common sense seems to be in short supply these days.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- minimum number of subject in bioequivalence study khaoula 2014-09-27 11:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- minimum number of subject in bioequivalence study ElMaestro 2014-09-27 11:26
- minimum number of subject in bioequivalence study khaoula 2014-09-27 23:49
- “Overpowered” studies due to GLs Helmut 2014-09-28 01:13
- “Overpowered” studies due to GLs khaoula 2014-09-28 22:36
- “Overpowered” studies due to GLs Helmut 2014-09-29 03:51
- Scientific Validation for the Sample Size Formula mreyes 2014-11-07 19:47
- Basic maths Helmut 2014-11-07 20:09
- Basic maths mreyes 2014-11-07 20:47
- Reference for CI ⇒ MSE Helmut 2014-12-14 01:51
- Reference for CI ⇒ MSE mreyes 2015-02-19 19:50
- Failed study: power <80%! Helmut 2015-02-20 19:09
- Failed study: power <80%! mreyes 2015-02-23 17:07
- Reported 99.98%, correct 1.4% Helmut 2015-02-23 17:38
- Reported 99.98%, correct 1.4%ElMaestro 2015-02-23 17:51
- GMR ∉ AR ⇒ power <5% Helmut 2015-02-24 01:33
- GMR ∉ AR ⇒ power <5% mreyes 2015-02-24 17:34
- GMR ∉ AR ⇒ power <5% Helmut 2015-02-24 01:33
- Reported 99.98%, correct 1.4%ElMaestro 2015-02-23 17:51
- Reported 99.98%, correct 1.4% Helmut 2015-02-23 17:38
- Failed study: power <80%! mreyes 2015-02-23 17:07
- Failed study: power <80%! Helmut 2015-02-20 19:09
- Reference for CI ⇒ MSE mreyes 2015-02-19 19:50
- Basic maths Helmut 2014-11-07 20:09
- “Overpowered” studies due to GLs khaoula 2014-09-28 22:36
- “Overpowered” studies due to GLs Helmut 2014-09-28 01:13
- minimum number of subject in bioequivalence study khaoula 2014-09-27 23:49
- minimum number of subject in bioequivalence study ElMaestro 2014-09-27 11:26
Ing. Helmut Schütz