Bioequivalence and Bioavailability Forum

Dear All,

Good Morning!

Please let me guide, how to select the number of sets in In-Vitro Kinetic and Equilibrium Binding study. As per the Sevelamer Hydrochloride OGD, Each binding study should be repeated at least 12 times.

1. Is there any procedure to find the number of sets (sample size) required for equilibrium
study.
2. The Slope and Intercept was calculated using the Linear Regression and the obtained
intercept was found to be in negative for some sets. Is it acceptable by regulatory,
Specially USFDA?

your quick response is appreciable.

Thanks in Advance

Thanks and Regards

G. Siva Krishna Teja,
Biostatistician.