Bioequivalence and Bioavailability Forum

Salam Mokhtar,

❝ 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 C_max, AUC_0–t, and AUC_0–∞.
In most other jurisdictions only C_max are AUC_0–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 C_max > AUC_0–∞ > AUC_0–t. Hence, passing C_max but failing AUC_0–∞ 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 repair or  replace it.