No of Vonteers requirment [Power / Sample Size]

posted by Srinetram – India, 2015-01-08 07:41 (3367 d 02:37 ago) – Posting: # 14244
Views: 6,459

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

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