Bioequivalence and Bioavailability Forum • Sample Size Estimation -Replicate design- BE limits

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

posted by cakhatri – India, 2017-11-30 10:44 (2332 d 16:10 ago) – Posting: # 18024
Views: 15,723

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

Regards
Chirag

Complete thread:

Sample Size Estimation -Replicate design- BE limitscakhatri 2017-11-30 09:44
- Reference-scaling: Don’t use FARTSSIE! Helmut 2017-11-30 10:58
  - Reference-scaling: Don’t use FARTSSIE? Astea 2017-11-30 22:50
    - Reference-scaling: Don’t use FARTSSIE! Helmut 2017-12-01 11:42
      - Reference-scaling: USE PowerTOST Astea 2017-12-01 14:16
        
        Reference-scaling: USE PowerTOST cakhatri 2017-12-04 06:00
        
        Reference-scaling: USE PowerTOST Helmut 2017-12-04 15:07
        
        Reference-scaling: USE PowerTOST cakhatri 2017-12-05 05:33
        
        Use PowerTOST d_labes 2017-12-06 09:52
        
        Use PowerTOST, not Endrényi L, Tóthfalusi L tables mittyri 2017-12-07 16:03
        
        Precision in Endrényi L, Tóthfalusi L tables d_labes 2017-12-07 18:21
        
        Precision of PowerTOST mittyri 2017-12-08 22:56
        
        Precision of PowerTOST Helmut 2017-12-09 17:00
        
        Precision of PowerTOST mittyri 2017-12-09 21:05
        
        Precision of PowerTOST Astea 2017-12-10 00:10
        
        Precision of PowerTOST Helmut 2017-12-10 20:27
        
        Precision of PowerTOST Astea 2017-12-10 21:13
  - Reference-scaling: Don’t use FARTSSIE! pjs 2018-02-09 13:08
    - Reference-scaling: Don’t use FARTSSIE! Helmut 2018-02-09 20:15