Revalidation? [Study As­sess­ment]

posted by mittyri – Russia, 2019-12-18 17:52 (1613 d 19:34 ago) – Posting: # 20997
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Hi Helmut and Dan,

❝ ❝ […] 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?

Kind regards,
Mittyri

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