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RegisterRevalidation? [Study Assessment]
Hi Helmut and Dan,
I heard about approach when the method is revalidated taking into account Cmax values of that subjects (LLOQ should be less than 5% min Cmax of those) and then the affected volunteers are reanalyzed (of course till the moment of database lock). What do you think?
❝ ❝ […] no detected concentrations in the predose samples for these subjects.
❝ Yep but the method was not sensitive enough for these subjects. Hence, I support Dan’s suggestion (exclude the subjects and check whether you still pass BE).
I heard about approach when the method is revalidated taking into account Cmax values of that subjects (LLOQ should be less than 5% min Cmax of those) and then the affected volunteers are reanalyzed (of course till the moment of database lock). What do you think?
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Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- BEQ inquiry from health authority Aymanmy 2019-12-18 08:51 [Study Assessment]
![[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