Log in
RegisterChange in curve changed the ratio of Cmax [Bioanalytics]
Dear Compliance
So the difference in Cmax ratio is due to the different number of test/reference comparisons since you now have additional profiles which were not available before due to the poor sensitivity of the first method, right?
In this case the first method is not appropriate to evaluate the study. According to the European BE guidelines the lower limit of quantitation should be 1/20 of Cmax or lower, as pre-dose concentrations should be detectable at 5% of Cmax or lower. I do not know if EMA considers the mean Cmax or the individual profiles. How many subjects/periods do you have with a Cmax between 0.25 ng/ml and 1.0 ng/ml?
However, to answer nobody´s question: The slopes of the individual profiles do not differ, right?
Kind regards
Dr_Dan
So the difference in Cmax ratio is due to the different number of test/reference comparisons since you now have additional profiles which were not available before due to the poor sensitivity of the first method, right?
In this case the first method is not appropriate to evaluate the study. According to the European BE guidelines the lower limit of quantitation should be 1/20 of Cmax or lower, as pre-dose concentrations should be detectable at 5% of Cmax or lower. I do not know if EMA considers the mean Cmax or the individual profiles. How many subjects/periods do you have with a Cmax between 0.25 ng/ml and 1.0 ng/ml?
However, to answer nobody´s question: The slopes of the individual profiles do not differ, right?
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 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 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 CmaxDr_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
Ing. Helmut Schütz