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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]
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]
Complete thread:
- Revalidate the studyKen Peh 2014-07-20 19:01 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Revalidate the study ElMaestro 2014-07-20 20:04
- α ≠ β Helmut 2014-07-20 22:33
Ing. Helmut Schütz