Bioequivalence and Bioavailability Forum

mokhtar saleh ☆ Egypt, 2017-10-24 18:58 (2755 d 02:30 ago) Posting: # 17912 Views: 7,352	AUC infinity [Study Assessment] Post reply
	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
★★★

Vienna, Austria,
2017-10-24 19:14
(2755 d 02:13 ago)

@ mokhtar saleh
Posting: # 17913
Views: 6,440

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 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 [image]

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mokhtar saleh ☆ Egypt, 2017-10-24 20:29 (2755 d 00:58 ago) @ Helmut Posting: # 17914 Views: 6,163	AUC infinity: primary for the FDA Post reply
	Thank you doctor But are there any country or guidance stat AUCinf as a primary parameter?? Edit: See this post #3. [Helmut ≠ doctor]

jag009 ★★★ NJ, 2017-10-27 07:42 (2752 d 13:46 ago) @ mokhtar saleh Posting: # 17932 Views: 6,198	AUC infinity: primary for the FDA Post reply
	❝ 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