Sample Size Estimation -Replicate design- BE limits [Power / Sample Size]

posted by cakhatri – India, 2017-11-30 10:44 (2427 d 04:37 ago) – Posting: # 18024
Views: 16,242

Dear All,

I would like to know

1.What BE limits should be taken into consideration while estimating sample size for replicate design studies for USFDA & EMA.

Should it be 80-125% ? We normally use FARTSSIE

Why the Question

1. For a product with 51% ISCV (from a completed partial replicate study UKMHRA) by using FARTSSIE we arrived at different sample size for EMA

- Sample size estimated = 27 (80% Power, 95-105% T/R, Method C1, BE Limits 69.84 to 143.19%)
- Sample size estimated = 76 (80% Power, 95-105% T/R, No reference Scaled BE Limits-80-125%)

Which sample size should we consider for pivotal study


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