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

posted by d_labes  – Berlin, Germany, 2013-03-05 11:12 (2994 d 11:27 ago) – Posting: # 10153
Views: 19,274

Dear ratnakar,

the 80% coverage of AUC(0-tlast) in relation to AUC(0-inf) is specified further in the EMA guidance under the heading "Reasons for exclusion":
"As stated in section 4.1.4, AUC(0-t) should cover at least 80% of AUC(0-∞). Subjects should not be excluded from the statistical analysis if AUC(0-t) covers less than 80% of AUC(0-∞), but if the percentage is less than 80% in more than 20% of the observations then the validity of the study may need to be discussed."

I interpret the 20% of observations as 20% of AUC values i.e. 2xsubjects in a classical 2x2x2 crossover.

Don't ask me how the validity of the study may be discussed. Duno.

Regards,

Detlew

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