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RegisterAUCt not covering at least 80% of AUCinf [Regulatives / Guidelines]
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.
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
Regards,
Detlew
Complete thread:
- AUCt not covering at least 80% of AUCinf ratnakar1811 2013-03-05 08:30 [Regulatives / Guidelines]
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- Gedankenexperiment Helmut 2020-06-07 12:41
- Carrot and whip Astea 2020-06-06 21:11
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- AUCt not covering at least 80% of AUCinf Astea 2020-06-05 19:05
- AUCt not covering at least 80% of AUCinf ratnakar1811 2013-03-06 08:50
- AUCt not covering at least 80% of AUCinfd_labes 2013-03-05 11:12
Ing. Helmut Schütz