Reanalysis of volunteers [Study As­sess­ment]

posted by Loky do – Egypt, 2022-03-16 09:10 (61 d 10:58 ago) – Posting: # 22838
Views: 362


After bioanalysis of 30% of volunteers in a bioequivalence study, the terminal phase samples of those volunteers were not adequately detected, a partial validation will be performed to lower the LLOQ to be able to detect those samples, is it accepted to reanalyze those volunteers? could it raise questions by authorities? as it may bias the outcome of the study, or just to analyze the rest of volunteers after lowering the LLOQ and use their data along with the 30% volunteers in calculations?

Thanks in advance

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