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RegisterAUC infinity [Study Assessment]
Is AUC0-inf a primary parameter for assessing Bioequivalence or secondary ??? I mean in a Bioequivalence study the C.I of cmax and AUC0-t were in the accepted range of Bioequivalence but AUC0-inf outside the range, can the study be accepted??
Although the drug is not a highly variable drug????
Edit: Please follow the Forum’s Policy. [Helmut]
Although the drug is not a highly variable drug????
Edit: Please follow the Forum’s Policy. [Helmut]
Complete thread:
- AUC infinitymokhtar saleh 2017-10-24 16:58
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- AUC infinity: primary for the FDA Helmut 2017-10-24 17:14
- AUC infinity: primary for the FDA mokhtar saleh 2017-10-24 18:29
- AUC infinity: primary for the FDA jag009 2017-10-27 05:42
- AUC infinity: primary for the FDA mokhtar saleh 2017-10-24 18:29
- AUC infinity: primary for the FDA Helmut 2017-10-24 17:14
Ing. Helmut Schütz