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

posted by ElMaestro  – Denmark, 2021-04-23 10:40 (1040 d 19:19 ago) – Posting: # 22313
Views: 1,971


❝ I have a question on the inclusion of a subject with missing three consecutive sampling points in the elimination phase. The subject followed the procedures through 8 hr sampling points and left for an emergency. The half life of the drug is 12 hours. the subject is willing to join the next periods. Whether that subject will be included in the PK analysis and /or statistical analysis if allowed in the next periods ?

Isn't that the wrong question?
I mean why would you include the subject for period 2 if not using her/his data? For production of tolerance/safety data only?

The question is more likely whether or not the subject should be invited to complete the study. I think she/he should, if you can make of her/his data. Three missings in the elimination phase is not a show-stopper, however annoying it may be. If you do not have SOPs or a protocol that somehow provides for exclusion I think the subject is still in the study.
At some CROs a subject going home in period 1 on own will or due to an AE is a lost/discontinued subject, while at other CROs subjects can come back for period 2 in such cases. It isn't a situation that is well defined by guidance.

Good luck with the rest of the study.

Pass or fail!

Complete thread:

UA Flag
 Admin contact
22,912 posts in 4,806 threads, 1,636 registered users;
36 visitors (0 registered, 36 guests [including 6 identified bots]).
Forum time: 04:59 CET (Europe/Vienna)

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

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