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Dear Ratnakar,
Apologies that I missed that important point...it will always be the actual time points for PK calculation whenever the deviation is more than the acceptable limits as defined in SOP or protocol.
As I said earlier, acceptable limit can be taken as ± 2 min (usually plus but very rarely we observe negative deviation also
so better to keep both the limits) for all the blood samplings and we need to take scheduled sampling time points for PK calculation when the sampling is done within defined limits ( i.e. within ± 2 min). This way, we will be taking actual sampling time points only for those cases where it will be a protocol deviation (a cross-check also). I hope, I was able to answer your question
Regards,
Pankaj Mishra
❝ Thanks for reply! what about the consideration of actual time or schedule time in PK analysis?
Apologies that I missed that important point...it will always be the actual time points for PK calculation whenever the deviation is more than the acceptable limits as defined in SOP or protocol.
As I said earlier, acceptable limit can be taken as ± 2 min (usually plus but very rarely we observe negative deviation also
so better to keep both the limits) for all the blood samplings and we need to take scheduled sampling time points for PK calculation when the sampling is done within defined limits ( i.e. within ± 2 min). This way, we will be taking actual sampling time points only for those cases where it will be a protocol deviation (a cross-check also). I hope, I was able to answer your question Regards,
Pankaj Mishra
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Pankaj Mishra
Pankaj Mishra
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 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 samplingPankaj Mishra 2009-12-11 10:49
- Actual vs. scheduled time Helmut 2009-12-11 14:03
- blood samplingPankaj 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