BEQ inquiry from health authority [Study As­sess­ment]

posted by Aymanmy – Jordan, 2019-12-18 08:51  – Posting: # 20990
Views: 779

Hi colleagues
Recently we submitted a BE study to EU, and we recieved an inquiry about in some subjects (5 out of 60) the LLOQ is more than 5% of the Cmax, plz need to know how can we reply about this case since the method was applicable for more than 90% of the subjects in the study and the LLOQ is actually less than 5% of the average Cmax, and no detected concentrations in the predose samples for these subjects.
Kind regards


Edit: Category changed; see also this post #1[Helmut]

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