Ci > Ci-1 (excluding data points) [NCA / SHAM]

posted by jag009  – NJ, 2012-03-26 17:24 (4798 d 03:41 ago) – Posting: # 8335
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Hi Helmut,

❝ ❝ Should Kel be labelled as "Undefined"? Some CROs would say "Undefined" …


❝ That would mean excluding the subject’s AUCs (AUCt unreliable, AUC undefined). At least you could keep the subject’s Cmax in the data set (which is more variable).


Actually that particular CRO (maybe there are others) kept the subject's Cmax, Tmax and AUCt but assigned AUCinf, kel and t1/2 as undefined or "N.C."

One more question, what if the last two points of the elimination phase is going in the positive direction and the points before them (lets say 3 points, yes after Cmax) are declining?

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