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Dear HS and forum members,
This topic was discussed long back, but recently i have received a letter from WHO for using actual time for PK analysis, as earlier we were considering schedule time if the deviation is <10% and for deviation >10% actual time.
Generally we have a window of 2 min for inhouse sampling and for ambulatory samples we have a window of 1 hr mentioned in the protocol, now my question is should we use actual time for all the deviation irrespective as mentioned above (i.e. even the sample is delayed by 1 min also) or for only those samples for which protocol deviation required to be filed?
Currently we have mentioned actual time to be considered for all the deviations even it is for 1 min also.
Your views will be highly aprreciated.
Regards,
Ratnakar
❝ 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.
This topic was discussed long back, but recently i have received a letter from WHO for using actual time for PK analysis, as earlier we were considering schedule time if the deviation is <10% and for deviation >10% actual time.
Generally we have a window of 2 min for inhouse sampling and for ambulatory samples we have a window of 1 hr mentioned in the protocol, now my question is should we use actual time for all the deviation irrespective as mentioned above (i.e. even the sample is delayed by 1 min also) or for only those samples for which protocol deviation required to be filed?
Currently we have mentioned actual time to be considered for all the deviations even it is for 1 min also.
Your views will be highly aprreciated.
Regards,
Ratnakar
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 Cmax Helmut 2007-11-09 17:27
- blood samplingratnakar1811 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