AUC infinity: primary for the FDA [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-24 17:14  – Posting: # 17913
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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 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 repair or  replace it.

Cheers,
Helmut Schütz
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