sample size in bioequivalence studies [Power / Sample Size]

posted by daryazyatina – Ukraine, 2017-08-03 11:34 (2429 d 03:56 ago) – Posting: # 17646
Views: 20,285

Hi, guys!

Today I have a new question related to the the sample size formula for average bioequivalence.

Before now I сalculated the sample size for ABE by formula:
[image]
(described in the book Shein-Chung Chow, Jun Shao and Hansheng Wang "Sample size calculations in clinical research" Copyright © 2003 by Marcel Dekker (Chapter 10. Bioequivalence Testing) http://www.crcnetbase.com/doi/book/10.1201/9780203911341)

I decided to try to calculate the sample size in R with package "PowerTOST" and function sampleN.TOST()

Comparing the results of the calculation in R and calculation with formula Shein-Chung Chow, Jun Shao and Hansheng Wang, I realized that they are different. I looked at the articles and books that this function refers to, and understand that different formulas are used.

On this basis, I had a question. What formula should I use to calculate the sample size for the ABE using two one-sided tests?

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