jocre (version 0.3.3)

marzo:

Description

Pharmacokinetic data from a study on the bioequivalence of a test and a reference formulation of ticlopidine hydrochloride in 24 healthy male volunteers, using a randomised crossover design (Marzo et al. 2002).

Usage

data("marzo")

Format

A data frame with 24 observations on the following 8 variables.

Volunteer

A numeric vector giving the volunteer ID.

Sequence

A factor with levels RT and TR specifying the sequence a volunteer was randomised to (R=reference, T=test).

Cmax_T

A numeric vector of the maximum concentration (Cmax) with the test product.

Cmax_R

A numeric vector of the maximum concentration (Cmax) with the reference product.

AUC_T

A numeric vector of the area under the concentration-time curve (AUC) from zero to the last observed time point with the test product.

AUC_R

A numeric vector of the area under the concentration-time curve (AUC) from zero to the last observed time point with the reference product.

AUCinf_T

A numeric vector of the area under the concentration-time curve AUC) from zero to infinity with the test product.

AUCinf_R

A numeric vector of the area under the concentration-time curve AUC) from zero to infinity with the reference product.

Details

The pharmacokinetic parameters (Cmax and AUC) were calculated using a non-compartmental approach. The data were taken from Tables I and II of Marzo et al. (2002).

References

Philip Pallmann & Thomas Jaki (2017) Simultaneous confidence regions and intervals for multivariate bioequivalence. Submitted to Statistics in Medicine.

Examples

data(marzo)

## An example analysis of Cmax assuming log-normality

# Difference of log(Cmax)
marzo$deltalogCmax <- log(marzo$Cmax_T) - log(marzo$Cmax_R)

# Estimated mean treatment effect with SE 
mean(marzo$deltalogCmax)
sd(marzo$deltalogCmax) / sqrt(nrow(marzo))

# Two one-sided test (TOST) p-values
t.test(x=marzo$deltalogCmax, alternative="less", mu=log(1.25))$p.value
t.test(x=marzo$deltalogCmax, alternative="greater", mu=log(0.80))$p.value

# 90% TOST confidence interval
t.test(x=marzo$deltalogCmax, conf.level=0.9)$conf.int[1:2]