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Hi Kishpokuri,
sample size in BE (regardless of whether we talk BE under the US or EU definition / regardless of whether we discuss PK or PD) will always be depending on your desired level of power, as well as the true (estimated) relative performance of your product (measured as OIP difference) and the variability associated with this similarity measure. So let's hear your thoughts about them. Add to that, please, some thoughts about dropout rates and your statistical model.
sample size in BE (regardless of whether we talk BE under the US or EU definition / regardless of whether we discuss PK or PD) will always be depending on your desired level of power, as well as the true (estimated) relative performance of your product (measured as OIP difference) and the variability associated with this similarity measure. So let's hear your thoughts about them. Add to that, please, some thoughts about dropout rates and your statistical model.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- sample size for clinical endpoint BE study of Brinzolamide 1% ophthalmic kishpokuri 2015-11-24 14:18 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- general remarkElMaestro 2015-11-24 16:50
- Specific remarks d_labes 2015-11-25 11:23
- Specific remarks kishpokuri 2015-11-27 13:46
Ing. Helmut Schütz