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RegisterChange in curve changed the ratio of Cmax [Bioanalytics]
Dear Ohlbe,
Yes. we also change the processing volume from 0.5 ml to 0.150 ml.
yes, first set of ISR is run and found satisfactory. second set is about to run of repeat study. However ISR of initial analysis is pass comfortably with around 90% acceptance.
I would like to add one thing that, i had done comparison of Cmax data between originally run assay and repeat study and found there is a difference of around 8-10% (negative side) and the same is getting reflected in the Cmax ratio.
some of the subject which are not getting qualify with initial range i.e. 1-800 ng/ml is getting qualify with the revised range 0.250 -250 and in that one of the period of test is showing very less concentration and this is affecting the ratio.
Please note this is 4 way crossover study.
Regards,
Compliance
❝ Was there any change in the method apart from the LLOQ ?
Yes. we also change the processing volume from 0.5 ml to 0.150 ml.
❝ Did you run ISR with both methods ? What was the outcome ?
yes, first set of ISR is run and found satisfactory. second set is about to run of repeat study. However ISR of initial analysis is pass comfortably with around 90% acceptance.
I would like to add one thing that, i had done comparison of Cmax data between originally run assay and repeat study and found there is a difference of around 8-10% (negative side) and the same is getting reflected in the Cmax ratio.
some of the subject which are not getting qualify with initial range i.e. 1-800 ng/ml is getting qualify with the revised range 0.250 -250 and in that one of the period of test is showing very less concentration and this is affecting the ratio.
Please note this is 4 way crossover study.
Regards,
Compliance
Complete thread:
- Change in curve changed the ratio of Cmax Compliance 2015-03-23 07:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Change in curve changed the ratio of Cmax Dr_Dan 2015-03-23 08:59
- Change in curve changed the ratio of Cmax Compliance 2015-03-23 09:27
- Change in curve changed the ratio of Cmax nobody 2015-03-23 09:19
- Change in curve changed the ratio of Cmax Compliance 2015-03-23 10:09
- Change in curve changed the ratio of Cmax nobody 2015-03-23 10:34
- Change in curve changed the ratio of Cmax Compliance 2015-03-23 10:53
- Change in curve changed the ratio of Cmax nobody 2015-03-23 10:34
- Change in curve changed the ratio of Cmax Compliance 2015-03-23 10:09
- Change in curve changed the ratio of Cmax Ohlbe 2015-03-23 14:13
- Change in curve changed the ratio of CmaxCompliance 2015-03-23 15:29
- Change in curve changed the ratio of Cmax nobody 2015-03-23 16:11
- Change in curve changed the ratio of CmaxCompliance 2015-03-23 15:29
- Change in curve changed the ratio of Cmax Dr_Dan 2015-03-24 08:15
- Change in curve changed the ratio of Cmax Compliance 2015-03-24 09:39
- Change in curve changed the ratio of Cmax Dr_Dan 2015-03-24 11:05
- Change in curve changed the ratio of Cmax Compliance 2015-03-25 12:13
- Change in curve changed the ratio of Cmax Dr_Dan 2015-03-23 08:59
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