Missing samples [Study As­sess­ment]

posted by Amira Gouda – Egypt, 2020-05-02 01:50 (1616 d 08:22 ago) – Posting: # 21383
Views: 4,600

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

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