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Registerif 75% of the subjects AUCt not covers at least 80% of AUCinf [Study Assessment]
Dear Rams
According to CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** AUC truncated at 72 h (AUC(0-72h)) may be used as an alternative to AUC(0-t) for comparison of extent of exposure as the absorption phase has been covered by 72 h for immediate release formulations. A sampling period longer than 72 h is therefore not considered necessary for any immediate release formulation irrespective of the half life of the drug.
So everything is fine.
I hope this helps
Kind regards
Dr_Dan
According to CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** AUC truncated at 72 h (AUC(0-72h)) may be used as an alternative to AUC(0-t) for comparison of extent of exposure as the absorption phase has been covered by 72 h for immediate release formulations. A sampling period longer than 72 h is therefore not considered necessary for any immediate release formulation irrespective of the half life of the drug.
So everything is fine.
I hope this helps
Kind regards
Dr_Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- if 75% of the subjects AUCt not covers at least 80% of AUCinf rams 2016-03-15 06:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- if 75% of the subjects AUCt not covers at least 80% of AUCinfDr_Dan 2016-03-15 08:49
- Protocol / SAP? Helmut 2016-03-15 14:32
- Protocol / SAP? rams 2016-03-23 05:31
- Protocol / SAP? Helmut 2016-03-15 14:32
- if 75% of the subjects AUCt not covers at least 80% of AUCinf Ohlbe 2016-03-23 09:44
- if 75% of the subjects AUCt not covers at least 80% of AUCinfDr_Dan 2016-03-15 08:49
Ing. Helmut Schütz