Back to the Top
Dear All,
For the bioequvalence study as far as I remember the AUC0-t for each subject that we can used for evaluation should be more than 80% of the AUC0-inf. But I could not remember the reference for this ratio. If any one have the reference for this please let me know. If the ratio is less than 80%, should we exclude the data of that subject from statistical analysis? How's about if there are almost 20% of subjects have this raio less than 80%. I think it may be due to the assay technique that not sensitive enough to detect the lower concentration.
Best Regards,
Wichittra
Back to the Top
The following message was posted to: PharmPK
Dear Wichittra,
> For the bioequvalence study as far as I remember the AUC0-t for each
> subject that we can used for evaluation should be more than 80% of the
> AUC0-inf. But I could not remember the reference for this ratio. If any
> one have the reference for this please let me know.
>
See this post:
http://forum.bebac.at/mix_entry.php?id=3730
> If the ratio is less than 80%, should we exclude the data of that
> subject from statistical analysis?
Well, cough... ;-)
First of all, don't start the statistical analysis - I hope your data a
still not unblinded. Regulators will be suspicious anyway
('cherry-picking'). Think about a solution (what's your primary metric?
If AUCinf, consider changing to AUClast; for e.g. the FDA you are in a
bad position - both AUCinf and AUClast have to meet BE criteria).
> How's about if there are almost 20% of subjects have this
> raio less than 80%.
Bad again. Some authorities have a limit for exclusion (e.g. Brazil's
ANVISA 15% of data).
> I think it may be due to the assay technique that not sensitive
> enough to detect the lower concentration.
Yes, that's the nice possibilty. Try to improve the analytical method
and reanalyse your samples, and you will be back in the game.
The other possibility is nasty, namely a too short sampling scheme.
That's a design error. Remark: *Never* plan a BE study based on
published *mean* half lives.
Best regards,
Helmut
-
Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "AUC greater than 80% of AUC(inf)" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)