Bioequivalence and Bioavailability Forum

Dear All

A very good morning

There is a question related to sample size which has always haunted me and I would be happy if anyone can please answer me that with proper explanation

Que: Which study (For EMEA or FDA) will need higher number of volunteer assuming drug is highly variable. (ISCV>30%)

I always say it would be FDA as one have to meet the 95% Upper confidence interval but was always unable to explain that in detail.

Was I right when I said number of volunteers required will be higher in EMEA?

What will be the scenario in cases where ISCV is >50% (lets say 60%)?
Study meant for EMEA will need higher number of volunteers as the CI limits would be fixed.

Please correct me if I got it all wrong

Thanks in advance for your help/suggestion


Regards
Srinetram