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RegisterA Nightmare on Elm Street [Study Performance]
posted by Helmut 
– Vienna, Austria, 2013-09-13 02:55 (4315 d 10:05 ago) – Posting: # 11490
Views: 10,142
Hi John,
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?
Splendid. As you posted before I thought I have seen everything – but this?!
Sure. AP hits.
The latter (OK, the second one at 4:15). Set the first one to “missing”, “not reportable“, or “oops”.
❝ 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”.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- Boneheads! jag009 2013-09-09 21:12
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- WTF ? Ohlbe 2013-09-09 21:26
- Snafued! Helmut 2013-09-09 21:55
- Snafued! WTF! &%$@! jag009 2013-09-10 16:11
- pAUCs Helmut 2013-09-11 21:01
- pAUCs - the SEQUEL jag009 2013-09-12 20:48
- A Nightmare on Elm StreetHelmut 2013-09-13 00:55
- A Nightmare on Elm Street jag009 2013-09-13 15:26
- A Nightmare on Elm Street Helmut 2013-09-13 16:00
- A Nightmare on Elm Street jag009 2013-09-13 19:57
- A Nightmare on Elm Street Helmut 2013-09-13 16:00
- A Nightmare on Elm Street jag009 2013-09-13 15:26
- A Nightmare on Elm StreetHelmut 2013-09-13 00:55
- pAUCs - the SEQUEL jag009 2013-09-12 20:48
- pAUCs Helmut 2013-09-11 21:01
- Snafued! WTF! &%$@! jag009 2013-09-10 16:11
- WTF ? jag009 2013-09-10 16:13
- Snafued! Helmut 2013-09-09 21:55
- WTF ? Ohlbe 2013-09-09 21:26
Ing. Helmut Schütz