Bioequivalence and Bioavailability Forum

Hello Everyone,

I was going through the FDA guidelines on establishing In-vitro Bioequivalence as it was suggested for Sevelamer. It has been mentioned to calculate two values, K1 and K2, using regression. And then bioequivalence shall be concluded on the basis of 90% CI for K2 for Equilibrium binding study. So, two questions popped up in my mind:

1) How many times an experiment setup should be repeated or in other words, what should be the sample size?

2) Which method should be used for the calculation of 90% CI?


Thanks,
GSTATS
www.gstatsolutions.com

Copypasted below from a deleted follow-up post; no necessity to reply to yourself within 24 hours – edit instead. See the Policy FAQ #3. [Helmut]

In an interim guidance for CHOLESTYRAMINE POWDER, FDA has quoted "The experiment should be repeated six times under the conditions described above to obtain six sets of data."

But in that case, my concern is very small sample size to say anything or to apply any method to estimate 90% Confidence Intervals.