Revalidation? [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-12-18 16:40 2a02:8388:6bc2:ce80:6c4e:e4df:42f4:6510 – Posting: # 21000
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Hi Mittyri,

» […] 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?

Yes, why not? As long as the data are not unblinded, it should not hurt. However,

» Recently we submitted a BE study to EU…

(my emphasis)

Hence, it can be just another kind of sensitivity analysis.

Posting # 21,000. :-D

Helmut Schütz

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