Missing three consecutive samples in the elimination phase [Study Per­for­mance]

posted by Ohlbe – France, 2021-04-23 14:50 (91 d 03:59 ago) – Posting: # 22321
Views: 571

Dear PVRC,

» The subject followed the procedures through 8 hr sampling points and left for an emergency. The half life of the drug is 12 hours.

What we're missing here is the expected tmax. What does the reference information of the reference product say ? If you have past experience on the same active substance, what was the latest tmax you had ?

You might keep the subject and use his data for Cmax but not for AUC. Considering the little impact that one single subject will have on power, I would however rather consider him as a drop out and avoid potential nasty discussions. This being said, if this is for the same 4-treatment William's design study for which you posted other messages today, it might be possible to exclude this period and keep his data for the other 3. If so, this must be defined and documented now, before the next period.


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