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RegisterAberrant observation in Reference (EU) for FDC [PK / PD]
Dear Hiren!
Did you calculate the geometric mean of the AUC of the Reference without the aberrant value?
EMA guidance page 14: "...A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject)..." Emphasis by me.
I would expect a ratio T/R around 20 if the aberrant value is 5% of the mean.
❝ What shall be done if T/R for single subject is around 1000 due to very low R value. No issues in clinical/bio analytical conduct.
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❝ As per EU we calculated whether its AUC is less than 5% of average GLSM for reference.
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❝ But the value comes to 5.80
Did you calculate the geometric mean of the AUC of the Reference without the aberrant value?EMA guidance page 14: "...A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject)..." Emphasis by me.
I would expect a ratio T/R around 20 if the aberrant value is 5% of the mean.
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Regards,
Detlew
Regards,
Detlew
Complete thread:
- Aberrant observation in Reference (EU) for FDC hiren379 2011-08-09 03:22
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