test_2x2_dom: Simulate a 2x2 Crossover Design and Compute Difference of...

In SimTOST: Sample Size Estimation for Bio-Equivalence Trials Through Simulation

Simulate a 2x2 Crossover Design and Compute Difference of Means (DOM)

Description

Simulates a two-sequence, two-period (2x2) crossover design and evaluate equivalence for the difference of means (DOM).

Usage

test_2x2_dom(
  n,
  muT,
  muR,
  SigmaW,
  lequi_tol,
  uequi_tol,
  alpha,
  sigmaB,
  dropout,
  Eper,
  Eco,
  typey,
  adseq,
  k,
  arm_seed
)

Arguments

n	integer number of subjects per sequence
muT	vector mean of endpoints on treatment arm
muR	vector mean of endpoints on reference arm
SigmaW	matrix within subject covar-variance matrix across endpoints
lequi_tol	vector lower equivalence tolerance band across endpoints
uequi_tol	vector upper equivalence tolerance band across endpoints
alpha	vector alpha value across endpoints
sigmaB	double between subject variance (assumed same for all endpoints)
dropout	vector of size 2 with dropout proportion per sequence (0,1)
Eper	vector of size 2 with period effect on period (0,1)
Eco	vector of size 2 with carry over effect of arm c(Reference, Treatment).
typey	vector with positions of primary endpoints
adseq	boolean is used a sequential adjustment?
k	integer minimum number of equivalent endpoints
arm_seed	seed for the simulation

Value

A numeric matrix containing the simulated hypothesis test results. The first column represents the overall equivalence decision, where 1 indicates success and 0 indicates failure. The subsequent columns contain the hypothesis test results for each endpoint, followed by mean estimates for the reference and treatment groups, and standard deviations for the reference and treatment groups.

SimTOST documentation built on April 3, 2025, 9:05 p.m.