Missing samples [Study As­sess­ment]

posted by Amira Gouda – Egypt, 2020-05-01 23:50 (378 d 16:50 ago) – Posting: # 21383
Views: 2,479

Hi ElMaestro,

thanks for your reply

» This guy is clearly not participating PP, his AUC is not outright a meaningful indicator of product performance, so out he goes, I think.

Yes, he actually missed the terminal phase, his AUC0-t is about 17% of his AUC0-inf, also check his figure

[image]

What we could do?

1- Extrapolate to 72 h
2- Use AUC common (0-12)
3- or based on the results of the current study could we make another stage on 12 subjects (knowing that the first one was performed on 24)?
4- Exclude the subject from stat evaluation of AUC(0-t) and include in all other parameters (as long as it does not jeopardize the acceptance of the study)

looking forward to your opinion
thanks

Complete thread:

Activity
 Admin contact
21,462 posts in 4,487 threads, 1,514 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time: Saturday 16:40 CEST (Europe/Vienna)

By all means let’s be open-minded, but not so open-minded
that our brains drop out.    Richard Dawkins

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5