Bioequivalence and Bioavailability Forum

Hello All,

I have very limited knowledge on Sample size calculation for Clinical Endpoint study.

I was serched for the same in this forum. Bt I didn't get clear idea on calculation of sample size.

I have the blow information to calculate Sample size.

Study Title: "RANDOMIZED, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY, COMPARING TEST Vs. RLD"

RLD appears to produce a percent reduction for IL that could be as low as 55.8% and vehicle %reduction can be as high as 41.5% after 12 weeks of treatment.

For NIL, the %reduction for RLD appears to be approximately 43.5% with vehicle producing as high as 27.9% reduction.

The anticipated standard deviation for IL and NIL is 36% for active treatment and 45% for vehicle treatment.

The sample size should sufficient to show superiority b/w Test, RLD Vs. Vehicle and equivalence b/w Test Vs. RLD.

My doubt is, whether we need to calculate seperate sample size for superiority and equivalence or at the same time.

Any SAS code or R code availabe for the same. Kindly suggest something on this.

Thanks in advance,
Regards,
GM.