Assumptions for powering a XO study [Power / Sample Size]

posted by Laura R  – Israel, 2017-06-01 16:57 (2816 d 18:36 ago) – Posting: # 17439
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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]

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