Revalidate the study [Study As­sess­ment]

posted by Ken Peh – Malaysia, 2014-07-20 19:01  – Posting: # 13276
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Dear Members,

We ran a BE study on 24 subjects. Unfortunately, on the day of study, two subjects dropped out and 7 subjects worked night shift and could only reported to the trial site after midnight. We were told that the 7 subjects could not be considered as these subjects could not be proven to have fasted. The study passed with 15 subjects and CVintrasubject of AUC and Cmax were below 10%.

We were asked to revalidate the study since the power of study should be 24 subjects. How do we revalidate the study ? Can we use the posthoc CV to show that the power is more than 80% even with 15 subjects ?

Highly appreciate your comments.

Thank you.

Regards,
Ken


Edit: Category changed. [Helmut]

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