Outlier in fully replicate BE study [Outliers]

posted by Loky do – Egypt, 2021-06-16 00:49 (127 d 00:07 ago) – Posting: # 22414
Views: 1,306

Dear colleagues,

During bioanalysis of a fully replicate BE study for drug known to has a potential for back conversion (clopidogrel), one volunteer shows drug concentrations below LLOQ in 3 phases and only one phase (Reference product) shows very low drug concentration, no probability of not swallowing the tablets (mouth check was assured) what could be the reason of this results :confused:? Knowing that the ISR results for the study is accepted?
Thanks in advance

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