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Registerblood sampling [Study Performance]
posted by Helmut 
– Vienna, Austria, 2007-11-04 14:45 (6374 d 04:25 ago) – Posting: # 1279
Views: 24,204
Dear Ohlbe!
Not only in the results (as stated by G Pabst based on simulations), but even more pronounced in the context of bioequivalence. Deviations of AUCs obtained from scheduled sampling times instead of from the more correct actual ones simply mean out in the calculation of BE (point estimate, confidence interval).
A couple of years ago I evaluated quite a lot of studies in both ways to get some impressions. Results generally differed to less than 0.1% (!) in terms of BE…
Me too! I’m always suggesting to use actual sampling times, but everybody should be aware that the crucial point is not the method of calculation (actual vs planned), but the location of sampling points.
IMHO the most important region is around Cmax.
❝ Corrections for time deviations in AUC calculations usually result only in negligible differences in AUC results.
Not only in the results (as stated by G Pabst based on simulations), but even more pronounced in the context of bioequivalence. Deviations of AUCs obtained from scheduled sampling times instead of from the more correct actual ones simply mean out in the calculation of BE (point estimate, confidence interval).
A couple of years ago I evaluated quite a lot of studies in both ways to get some impressions. Results generally differed to less than 0.1% (!) in terms of BE…
❝ But as always, I prefer to see things planned and described in advance, either in the protocol or in SOPs.
Me too! I’m always suggesting to use actual sampling times, but everybody should be aware that the crucial point is not the method of calculation (actual vs planned), but the location of sampling points.
IMHO the most important region is around Cmax.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 samplingHelmut 2007-11-04 13:45
- blood sampling Dr.Tarak Parikh 2007-11-06 09:59
- First Time Cmax Helmut 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 samplingHelmut 2007-11-04 13:45
- blood sampling Ohlbe 2007-11-04 13:25
Ing. Helmut Schütz