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RegisterFirst Time Cmax [Study Performance]
posted by Helmut 
– Vienna, Austria, 2007-11-09 18:27 (6787 d 13:01 ago) – Posting: # 1293
Views: 27,423
Dear Tarak!
Wow! Tmax 12 minutes, the perfect analgesic!
It will be quite challenging to avoid FDA'shttp://www.fda.gov/cder/guidance/5356fnl.pdf First Point Cmax-problem (see Section VI.D). Sample as frequently as possible…
In order to avoid bias in the calculation of AUC consider method 9 by
Unfortunately this algorithm is not implemented in standard PK software; you would have to write your own routines – which is not very complicated anyhow.
Continue in any case; but be prepared to report the reason for the deviation(s) in detail.
Collection in the second period should be performed at the scheduled time; otherwise with such a short half life sampling at actual time points of period I for every subject you will end up in some kind of logistic chaos in period II.
Edit: Link corrected to latest archived copy. [Helmut]
❝ 1. if it is a IR product, Tmax-12min, and T1/2 - 1hr, then what?
Wow! Tmax 12 minutes, the perfect analgesic!
It will be quite challenging to avoid FDA's
In order to avoid bias in the calculation of AUC consider method 9 by
RD Purves
Optimum Numerical Integration Methods for Estimation of Area-Under-the-Curve (AUC) and Area-under-the-Moment-Curve (AUMC)
J Pharmacokin Biopharm 20/3, 211–26 (1992)
Unfortunately this algorithm is not implemented in standard PK software; you would have to write your own routines – which is not very complicated anyhow.
❝ 2. if deviation of blood collection is more than 5%, then should we continue the 2nd period?, if yes then should we collect the blood as per actual time point or schedule time?
Continue in any case; but be prepared to report the reason for the deviation(s) in detail.
Collection in the second period should be performed at the scheduled time; otherwise with such a short half life sampling at actual time points of period I for every subject you will end up in some kind of logistic chaos in period II.
Edit: Link corrected to latest archived copy. [Helmut]
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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. 🚮
Science Quotes
Complete thread:
- blood sampling drdds 2007-11-03 11:42 [Study Performance]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- blood sampling Ohlbe 2007-11-04 00:29
- blood sampling Helmut 2007-11-04 01:13
- blood sampling Ohlbe 2007-11-04 13:25
- blood sampling Helmut 2007-11-04 13:45
- blood sampling Dr.Tarak Parikh 2007-11-06 09:59
- First Time CmaxHelmut 2007-11-09 17:27
- blood sampling ratnakar1811 2009-12-10 07:05
- blood sampling Pankaj Mishra 2009-12-10 10:05
- blood sampling ratnakar1811 2009-12-10 12:46
- blood sampling Pankaj Mishra 2009-12-11 10:49
- Actual vs. scheduled time Helmut 2009-12-11 14:03
- blood sampling Pankaj Mishra 2009-12-11 10:49
- blood sampling ratnakar1811 2009-12-10 12:46
- blood sampling Helmut 2009-12-10 13:13
- blood sampling ratnakar1811 2009-12-11 10:16
- blood sampling Pankaj Mishra 2009-12-10 10:05
- blood sampling Dr.Tarak Parikh 2007-11-06 09:59
- blood sampling Helmut 2007-11-04 13:45
- blood sampling Ohlbe 2007-11-04 13:25
Ing. Helmut Schütz