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RegisterPlanning the study based on the previous results [Power / Sample Size]
Hi ElMaestro & Helmut,
I would like to continue the discussion on the practical level.
So we conducted the BEQ study on the Test product (50 mg).
Our results for Cmax were:
90%CI=[0.847; 1.134] CV=38%, PE=0.98, N=36
Does it mean that with a probability 90% the real GMR of Cmax lies between 0.847 and 1.134? Does it mean that the mentioned probability normally distributed in this interval?
We're planning to perform the second study with the same API, but another strength (100mg).
Which GMR would you propose? 0.98% (optimistic from previous study)? 0.95% (standard)?
I would like to continue the discussion on the practical level.
So we conducted the BEQ study on the Test product (50 mg).
Our results for Cmax were:
90%CI=[0.847; 1.134] CV=38%, PE=0.98, N=36
Does it mean that with a probability 90% the real GMR of Cmax lies between 0.847 and 1.134? Does it mean that the mentioned probability normally distributed in this interval?
We're planning to perform the second study with the same API, but another strength (100mg).
Which GMR would you propose? 0.98% (optimistic from previous study)? 0.95% (standard)?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Different strengths – different ISV? mittyri 2014-12-21 18:04 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different strengths – different ISV? ElMaestro 2014-12-21 20:42
- Different strengths – different ISV? Helmut 2014-12-22 03:07
- Different strengths – thanks for advice mittyri 2014-12-22 20:33
- Planning the study based on the previous resultsmittyri 2015-02-11 19:23
- Planning the study based on the previous results ElMaestro 2015-02-11 20:29
- Conservatism Helmut 2015-02-12 13:31
- Different strengths – different ISV? Helmut 2014-12-22 03:07
- Different strengths – different ISV? ElMaestro 2014-12-21 20:42
Ing. Helmut Schütz