Total CV from Literature [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2012-02-16 14:11 (5246 d 02:39 ago) – Posting: # 8130
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Dear Chiku!

❝ […] we have ANOVA for a Cross over study. This study was for the strength of 10 mg. Can we use total %CV obtained from this study to design a parallel study for 20 mg (there's pharmacokinetics linearity between 10 and 20 mg). I think we can use it because CV is a relative measure of variability, it is not absolute.


Yes, you can. For one of the APIs I have worked on the CVs were pretty reproducible in 10/20/30/40/60 mg studies (linear PK). Since CVtotal includes between-subject variability note that you have to keep the inclusion/exclusion criteria in the parallel study at least as stringent as in the cross-over. Don’t forget to add a safety margin.

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