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

posted by pjs – India, 2018-02-09 14:08 (2290 d 21:22 ago) – Posting: # 18388
Views: 12,616

Hi All,

❝ If you want to go with reference-scaling, none! They depend on the CVwR and are obtained in the actual study. Hence, you need simulations, where your assumed CVwR 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. :thumb up:


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

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