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RegisterAssumptions for powering a XO study [Power / Sample Size]
Hi Forum,
We are planning a XO BE study to support a manufacturing change, and have only data from a single administration (from which we extracted %CV).
In order to calculate sample size, do I need information regarding expected correlation between PK parameters in period 1 (test) vs period 2 (ref)? What would be a reasonable assumption when there is no prior data?
Thanks, Laura
Edit: Category changed; see also this post #1. [Helmut]
We are planning a XO BE study to support a manufacturing change, and have only data from a single administration (from which we extracted %CV).
In order to calculate sample size, do I need information regarding expected correlation between PK parameters in period 1 (test) vs period 2 (ref)? What would be a reasonable assumption when there is no prior data?
Thanks, Laura
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Assumptions for powering a XO studyLaura R 2017-06-01 14:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- CVintra ≠ CVtotal Helmut 2017-06-01 15:47
Ing. Helmut Schütz