Skip to content

Commit 9557a0e

Browse files
Added common intro para
1 parent cdd04ea commit 9557a0e

File tree

1 file changed

+3
-0
lines changed

1 file changed

+3
-0
lines changed

vignettes/sampleSize_parallel_3A1E.Rmd

Lines changed: 3 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -22,6 +22,9 @@ options(rmarkdown.html_vignette.check_title = FALSE) #title of doc does not matc
2222
doc.cache <- T #for cran; change to F
2323
```
2424

25+
In the `SimTOST` R package, which is specifically designed for sample size estimation for bioequivalence studies, hypothesis testing is based on the Two One-Sided Tests (TOST) procedure. [@sozu_sample_2015] In TOST, the equivalence test is framed as a comparison between the the null hypothesis of ‘new product is worse by a clinically relevant quantity’ and the alternative hypothesis of ‘difference between products is too small to be clinically relevant’. This vignette focuses on a parallel design, with 3 arms/treatments and 1 primary endpoint.
26+
27+
# Introduction
2528
This vignette demonstrates advanced sample size calculation techniques for parallel trial designs involving three arms and one endpoint. Specifically, we calculate the required sample size to test bioequivalence between a new treatment (SB2) and a reference product (Remicade) administered in two different locations ("EU_Remicade" and "USA_Remicade"). The endpoint of interest is the Area Under the Curve (AUCinf), a commonly used pharmacokinetic measure.
2629

2730
In this example, we assume the endpoint follows a log-normal distribution with equal variances across arms. The goal is to determine the sample size needed to achieve 90\% power while controlling the type I error rate at 5\%. The equivalence margin is defined as $E_L = 80\%$ and $E_U = 125\%$ of the reference mean on the original scale.

0 commit comments

Comments
 (0)