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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