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RegisterBEQ inquiry from health authority [Study Assessment]
Hi colleagues
Recently we submitted a BE study to EU, and we recieved an inquiry about in some subjects (5 out of 60) the LLOQ is more than 5% of the Cmax, plz need to know how can we reply about this case since the method was applicable for more than 90% of the subjects in the study and the LLOQ is actually less than 5% of the average Cmax, and no detected concentrations in the predose samples for these subjects.
Kind regards
Edit: Category changed; see also this post #1. [Helmut]
Recently we submitted a BE study to EU, and we recieved an inquiry about in some subjects (5 out of 60) the LLOQ is more than 5% of the Cmax, plz need to know how can we reply about this case since the method was applicable for more than 90% of the subjects in the study and the LLOQ is actually less than 5% of the average Cmax, and no detected concentrations in the predose samples for these subjects.
Kind regards
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- BEQ inquiry from health authorityAymanmy 2019-12-18 08:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BEQ inquiry from health authority Dr_Dan 2019-12-18 14:46
- Method not sensitive enough Helmut 2019-12-18 15:16
- Revalidation? mittyri 2019-12-18 16:52
- Revalidation? Helmut 2019-12-18 17:40
- Method not sensitive enough Aymanmy 2019-12-18 17:58
- Method not sensitive enough Helmut 2019-12-18 18:54
- Method not sensitive enough Aymanmy 2019-12-19 08:21
- Method not sensitive enough Helmut 2019-12-18 18:54
- Revalidation? mittyri 2019-12-18 16:52
Ing. Helmut Schütz