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Registerminimum number of subject in bioequivalence study [Power / Sample Size]
Hello Khaoula,
You're right you might get good level of power for N<12 but regulators have decided to set a limit and they set that limit at 12. Not sure there is a really good reason, but that's just the way it is.
Pick any number you like. But be aware that the value of a pilot study tends to be limited if you have few subjects. In this regard it is impossible to tell what "few" really means - that would depend on the actual GMR, its CV and the purpose of the pilot. Therefore, I'd say use as many subjects in the pilot as you can within the meaning of ethics and budgets and everything else.
❝ – Why the minimum simple size fixed by all regulatory authorities is 12? because when we consult the table of Sample Size for Schuirmann’s Two One-Sided t-Tests Procedure, we note that for low CV <15% the number of subject required is <12?
You're right you might get good level of power for N<12 but regulators have decided to set a limit and they set that limit at 12. Not sure there is a really good reason, but that's just the way it is.
❝ – in pilot study, we need small simple size, but could it be greater than 12?
Pick any number you like. But be aware that the value of a pilot study tends to be limited if you have few subjects. In this regard it is impossible to tell what "few" really means - that would depend on the actual GMR, its CV and the purpose of the pilot. Therefore, I'd say use as many subjects in the pilot as you can within the meaning of ethics and budgets and everything else.
—
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 studyElMaestro 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 studyElMaestro 2014-09-27 11:26
Ing. Helmut Schütz