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Sample size calculations (Ep. 41)

Sample size calculations (Ep. 41)

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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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