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

posted by ratnakar1811 – India, 2013-03-06 08:50 (2874 d 23:14 ago) – Posting: # 10157
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Dear d_labes/forum members,

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.

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?

Best Regards,

Ratnakar

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