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RegisterChange in curve changed the ratio of Cmax [Bioanalytics]
Dear Dr_Dan,
Yes.
A product in which we are working having issue with itself. actually it is not possible to get the consistent performance in healthy subject. it is locally acting and if we need to get success then the patient is the only option. Actual suggested LLOQ in SBOA is 5 ng/ml which was used at the initiation of the study and based on the experience of each repeated study we have revised the LLOQ.
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.
we are working on Meselamine and conventional approach could not work.
Regards,
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?
Yes.
❝ In this case the first method is not appropriate to evaluate the study.
A product in which we are working having issue with itself. actually it is not possible to get the consistent performance in healthy subject. it is locally acting and if we need to get success then the patient is the only option. Actual suggested LLOQ in SBOA is 5 ng/ml which was used at the initiation of the study and based on the experience of each repeated study we have revised the LLOQ.
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.
we are working on Meselamine and conventional approach could not work.
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 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 CmaxCompliance 2015-03-25 12:13
- Change in curve changed the ratio of Cmax Dr_Dan 2015-03-23 08:59
Ing. Helmut Schütz