AUC infinity: primary for the FDA [Study Assessment]
Salam Mokhtar,
Depends on what is stated in your statistical analysis plan.
For the FDA you have to demonstrate BE for Cmax, AUC0–t, and AUC0–∞.
In most other jurisdictions only Cmax are AUC0–t required.
In many cases the variability of these PK metrics ranks Cmax > AUC0–∞ > AUC0–t. Hence, passing Cmax but failing AUC0–∞ is unlikely but possible.
Doesn’t matter.
P.S.: Your keyboard’s got jammed numerous times. You should
repair or replace it.
❝ Is AUC0-inf a primary parameter for assessing Bioequivalence or secondary ???
Depends on what is stated in your statistical analysis plan.

For the FDA you have to demonstrate BE for Cmax, AUC0–t, and AUC0–∞.
In most other jurisdictions only Cmax are AUC0–t required.
❝ […] 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??
In many cases the variability of these PK metrics ranks Cmax > AUC0–∞ > AUC0–t. Hence, passing Cmax but failing AUC0–∞ is unlikely but possible.
❝ Although the drug is not a highly variable drug????
Doesn’t matter.
P.S.: Your keyboard’s got jammed numerous times. You should
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Complete thread:
- AUC infinity mokhtar saleh 2017-10-24 16:58 [Study Assessment]
- AUC infinity: primary for the FDAHelmut 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 FDAHelmut 2017-10-24 17:14