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RegisterChange in curve changed the ratio of Cmax [Bioanalytics]
Dear Compliance
You analysed the same samples with two different (fully validated?) methods and got two different results.
The observed change in Cmax ratio is not logical and acceptable and doubts on the method(s) can be raised.
This is not correct. If the change affected all samples you would have no difference in study results. In fact it seems that only the samples for the test formulation show differences between the concentration obtain during initial analysis and repeat Analysis. This is not logical.
I guess you have a severe Problem.
Kind regards
Dr_Dan
You analysed the same samples with two different (fully validated?) methods and got two different results.
❝ Now my question is does it impacted due to change in method (i.e. linearity) & processing volume? does the observed change in Cmax ratio is logical and acceptable or any doubt on the method can be raised?
The observed change in Cmax ratio is not logical and acceptable and doubts on the method(s) can be raised.
❝ Please note that the difference between the concentration obtain during initial analysis and repeat analysis is around 10-12%.
This is not correct. If the change affected all samples you would have no difference in study results. In fact it seems that only the samples for the test formulation show differences between the concentration obtain during initial analysis and repeat Analysis. This is not logical.
I guess you have a severe Problem.
Kind regards
Dr_Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
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 CmaxDr_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 Cmax Compliance 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 Cmax Compliance 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 CmaxDr_Dan 2015-03-23 08:59
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