Bioequivalence and Bioavailability Forum

Hello,

My concern is about accumulation ratio calculation after repeated administration of IR product.

Our study design was as follows: 2 periods for food effect assessment followed by 1 MD period (administration every 12h) where subjects received breakfast before administration.
1 sample collection was made for PK at the end of MD period. We would like to calculate accumulation ratio but we do not have single dose PK result from the MD period to assess it.
We have thought to use results from food effect for this assessment to get the information.

However, which results could we use according to you?
fast period? but subjects received usual breakfast during MD period
fed period? it seems to be the best solution as no food effect was shown for AUC parameter but food effect was observed for Cmax.

Second question, which formula could we use to assess this ratio?

I hope my question sounds clear enough..
Thanks by advance for your help

Kobe