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RegisterJustification of AUC0-72 usage and AP calculation [Regulatives / Guidelines]
Dear All,
According to the EU GL
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.
Do we need to put in the Protocol any justification about "the absorption phase has been covered by 72 h"?
Could you help with Absorption Phase calculation from literature data? I've found only a simple method
AP<2-4×tmax
(from Helmut's Lecture
)
According to the EU GL
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.
Do we need to put in the Protocol any justification about "the absorption phase has been covered by 72 h"?
Could you help with Absorption Phase calculation from literature data? I've found only a simple method
AP<2-4×tmax
(from Helmut's Lecture
)—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Justification of AUC0-72 usage and AP calculationmittyri 2014-06-10 20:05
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: No justification needed Helmut 2014-06-10 21:17
Ing. Helmut Schütz