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There have been significant recent improvements to the spreadsheet I
created in Excel to calculate sample sizes for clinical trials.
FARTSSIE is originally based on Stephen Julious' paper: Julious, SA.
Statist. Med. (2004); 23:1921-1986.
The program is available for download here:
The newest version doesn't require the Excel library Pifncs.xla to
work. It is a standalone spreadsheet that just requires loading in
Excel and enabling macros. In addition, it is compatible with Office
2007, whereas previous versions were not. If you've previously
downloaded FARTSSIE, I recommend downloading the most recent version.
FARTSSIE can calculate sample sizes for the following types of
- Superiority Trials: Parallel and 2-way Crossover
- Clinical Equivalence Trials: Parallel and 2-way Crossover
- Non-Inferiority Trials: Parallel and 2-way Crossover
- Bioequivalence Trials: Crossover, Replicate, and Parallel
- Trials to a Given Precision: Parallel and Crossover
- Difference Between Proportions (for smaller trials, up to 170
Also available on the above link is an updated summary of
Bioequivalence Guidances in Excel for the FDA, TPD, and EMEA.
David Dubins, Ph.D., B.Eng.
Global Bioequivalence Consulting
Assistant Professor, Leslie Dan Faculty of Pharmacy
University of Toronto
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