AUCt not covering at least 80% of AUCinf [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2013-03-06 12:10 (4062 d 23:59 ago) – Posting: # 10158
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Hello Ratnakar,

❝ Yes, in more than 20% of observations AUCinf has been extrapolated for more than 20% and i have received a query from EMA to discuss the validity of the study.

From EMA? I guess you mean from one or more of the national agencies?

❝ I am just thinking what all points should be considered for the justification and further is there any way by which it can be justified?

Try and tell why this happened in the first place. If it was not intended then I guess your study could be argued to be slightly badly planned for which there are no obvious and acceptable excuses. On the other hand if you deliberately shortened sampling time for some reason (PI opinion, ethics, ADME-tox properties) then please give a little further info and let's see.

Pass or fail!

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