Bioequivalence and Bioavailability Forum • Reference-scaling: Don’t use FARTSSIE!

Reference-scaling: Don’t use FARTSSIE! [Power / Sample Size]

posted by pjs – India, 2018-02-09 14:08 (3062 d 09:46 ago) – Posting: # 18388
Views: 16,451

Hi All,

❝ If you want to go with reference-scaling, none! They depend on the CV_wR and are obtained in the actual study. Hence, you need simulations, where your assumed CV_wR is the mean. Either use the tables provided by the two Lászlós* or package PowerTOST for R. The software is open source and comes free of costs.

For sample size estimation for highly variable drugs, simulations are required to estimate sample size.

Just wondering what parameters/variables are applied in the simulations being done like wise in the sample size suggested by Laszlo or by package powertost,

Also what could be impact of difference in variable assumption for simulation incase of borderline high and very large variability (like 30% and 300%), varying T/R ratios (100%, 80.01%) etc.

Regards
pjs

Complete thread:

Sample Size Estimation -Replicate design- BE limits cakhatri 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