Sample size calculations (Ep. 41)
Update: 2025-01-31
Description
In this episode I discuss power calculations using the R package PowerTOST. I gave an introduction to power calculations and the statistical premise. I reviewed bioequivalence study designs that are commonly used for generic drug development, food effect evaluation, and drug-drug interaction studies.
Links discussed in the show:
- PowerTOST R package
- PowerTOST instructions (scroll down to the Read Me information)
- Example R code (Change the filetype to .R after downloading)
- Statistical Power
- Statistical approaches to establishing Bioequivalence from FDA
- Calculation of CV
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