Log in
RegisterpAUCs - the SEQUEL [Study Performance]
Hi Helmut,
That's the beauty of it. It's not described on the protocol and CRO's SOP doesn't have this. Of course I can do a supplmental analysis myself...
Oh something NEW has popped up (I was looking at 50% of the subject, now I have 100%). 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
The concentration values are different.
@$^% !!!!! How the hell do you tackle this??? Should I take the average of the two concentrations and use only the 4 hr time point?
John
❝ Why not? As you know we work on the same drugs (pAUCs standard). Never had a problem. Of course I describe the procedure in the protocol and even give an example plot similar to that one …
That's the beauty of it. It's not described on the protocol and CRO's SOP doesn't have this. Of course I can do a supplmental analysis myself...
❝ I thought that you don’t have the 3.5 sample (delayed till 4:11)? But you have the one at 4:02. Interpolate between this one and the one before. If you feel that you are reaching to far “to the left”, drop the AUCs and keep the Cmax.
Oh something NEW has popped up (I was looking at 50% of the subject, now I have 100%). They have the following:
3.5 hr with a time deviation of 45 mins; Reason - Restick
4 hr with a time deviation of 15 mins; Reason - Restick
The concentration values are different.
@$^% !!!!! How the hell do you tackle this??? Should I take the average of the two concentrations and use only the 4 hr time point?
John
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! &%$@! jag009 2013-09-10 16:11
- pAUCs Helmut 2013-09-11 21:01
- pAUCs - the SEQUELjag009 2013-09-12 20:48
- A Nightmare on Elm Street Helmut 2013-09-13 00:55
- A Nightmare on Elm Street jag009 2013-09-13 15:26
- A Nightmare on Elm Street Helmut 2013-09-13 16:00
- A Nightmare on Elm Street jag009 2013-09-13 19:57
- A Nightmare on Elm Street Helmut 2013-09-13 16:00
- A Nightmare on Elm Street jag009 2013-09-13 15:26
- A Nightmare on Elm Street Helmut 2013-09-13 00:55
- pAUCs - the SEQUELjag009 2013-09-12 20:48
- pAUCs Helmut 2013-09-11 21:01
- Snafued! WTF! &%$@! 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