mokhtar saleh
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Egypt,
2017-10-24 16:58

Posting: # 17912
Views: 4,074
 

 AUC 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]
Helmut
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Vienna, Austria,
2017-10-24 17:14

@ mokhtar saleh
Posting: # 17913
Views: 3,549
 

 AUC infinity: primary for the FDA

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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mokhtar saleh
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Egypt,
2017-10-24 18:29

@ Helmut
Posting: # 17914
Views: 3,414
 

 AUC infinity: primary for the FDA

Thank you doctor
But are there any country or guidance stat AUCinf as a primary parameter??


Edit: See this post #3. [Helmut ≠ doctor]
jag009
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NJ,
2017-10-27 05:42

@ mokhtar saleh
Posting: # 17932
Views: 3,341
 

 AUC infinity: primary for the FDA

» But are there any country or guidance stat AUCinf as a primary parameter??

He said that already. FDA=USA needs BE for Cmax, AUCt and AUCi

J
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