Bioequivalence and Bioavailability Forum

Dear Shreyas,

❝ Can agency think like something done fishy?????

Well, with Agencies you never know, some people tend to be paranoid, but they have grown good reasons to be over the last years. However I would not be too worried.

❝ As drop out subjects will not be considered for statistical calculations, then why did the analysis been performed for drop out subjects?

Well, with ICH M10 you have to submit all chromatograms from all runs. They will easily be able to check that you only analysed samples from one period, so that is not a case of not liking the results of period 2 and then pretending that the subject dropped out from that period and changing the clinical records accordingly.

They may use tools (like DABERS or similar to Anders' SaToWIB) to check that the results of other subjects are not suspiciously similar to those of the dropout subjects.

In any case, if the samples have already been analysed, they have already been analysed and you cannot go backwards in time to de-analyse them. Just keep all records ready, and answer any question in a clear, honest and transparent manner.