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

posted by ratnakar1811 – India, 2013-03-05 08:30  – Posting: # 10151
Views: 6,692

Dear All,
As per EMA guideline AUC(0-t) should cover at least 80% of AUC(0-∞) but in one of my study I have got this percentage more than 20% and the % in the study is around 31%.

Is there any way by which I can justify this issue? Anybody has any such experience with the European regulators’?
Your views are highly appreciated.

Best Regards,

Ratnakar

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