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RegisterAnalytical range LOQ [Bioanalytics]
Dear Farmacevt,
There is always possibility that few subjects may have LLOQ of more than 5% Cmax as during the method development, the assumed Cmax is higher(compared to lower Cmax in observed) in current case. If the subjects are more than 20% having 1st time point of more than 5% Cmax, then there could be an issue with your CC range, but if less than 20% – it is generally good to submit the dossier.
To prevent the scenario in future, kindly take a range of Cmax for consideration of CC range. The lower Cmax can be considered for 5 or 6 half life consideration of LLOQ and upper Cmax for ULOQ consideration.
Regards,
dshah
❝ Please advise what if the Lower limit of quantification for some of the subjects in the BE study is greater than 5% of Cmax (not for the pre-dose concentrations).
There is always possibility that few subjects may have LLOQ of more than 5% Cmax as during the method development, the assumed Cmax is higher(compared to lower Cmax in observed) in current case. If the subjects are more than 20% having 1st time point of more than 5% Cmax, then there could be an issue with your CC range, but if less than 20% – it is generally good to submit the dossier.
To prevent the scenario in future, kindly take a range of Cmax for consideration of CC range. The lower Cmax can be considered for 5 or 6 half life consideration of LLOQ and upper Cmax for ULOQ consideration.
Regards,
dshah
Complete thread:
- Analytical range LOQ Farmacevt 2021-12-20 20:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Analytical range LOQ ElMaestro 2021-12-20 22:46
- Analytical range LOQ Farmacevt 2021-12-22 22:02
- Analytical range LOQdshah 2021-12-21 12:03
- LLOQ based on ‘worst case’ Cmax Helmut 2021-12-21 13:31
- LLOQ based on ‘worst case’ Cmax ElMaestro 2021-12-21 15:48
- LLOQ based on ‘worst case’ Cmax Helmut 2021-12-22 23:16
- LLOQ based on ‘worst case’ Cmax ElMaestro 2021-12-21 15:48
- Analytical range LOQ ElMaestro 2021-12-20 22:46
Ing. Helmut Schütz