Sample size calculations (Ep. 41)

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Clinical Pharmacology Podcast with Nathan Teuscher

Nathan Teuscher

50 episodes

1 week ago

I discuss clinical pharmacology and pharmacometrics topics from the perspective of drug development scientists. I share my expertise and knowledge about designing and conducting clinical pharmacology studies and discuss how to analyze the data using the most effective approaches. I draw from my experience of over 20 years working in drug development organizations and consultancies.

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Sample size calculations (Ep. 41)

Clinical Pharmacology Podcast with Nathan Teuscher

34 minutes 39 seconds

9 months ago

Sample size calculations (Ep. 41)

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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