Revalidation? [Study Assessment]
❝ ❝ […] 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?
- BEQ inquiry from health authority Aymanmy 2019-12-18 08:51 [Study Assessment]
- BEQ inquiry from health authority Dr_Dan 2019-12-18 14:46
- Method not sensitive enough Helmut 2019-12-18 15:16