A Nightmare on Elm Street [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2013-09-13 02:55 (4259 d 08:57 ago) – Posting: # 11490
Views: 9,819

Hi John,

❝ It's not described on the protocol and CRO's SOP doesn't have this.


So in the protocol they simply copypasted from the guidance “AUC0-4, AUC4-t, AUC0-∞, and Cmax, where AUC0-4 is the area under the plasma-concentration vs. time curve from 0 to 4 hours, AUC4-t is area under the curve from 4 hours to the last measurable time point” without stating the algo? Brilliant. Which software are they using?

❝ They have the following:

❝ 3.5 hr with a time deviation of 45 mins; Reason - Restick

❝ 4 hr with a time deviation of 15 mins; Reason - Restick


Splendid. As you posted before I thought I have seen everything – but this?!

❝ The concentration values are different.


Sure. AP hits.

❝ How the hell do you tackle this??? Should I take the average of the two concentrations and use only the 4 hr time point?


The latter (OK, the second one at 4:15). Set the first one to “missing”, “not reportable“, or “oops”.

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