skin {cTOST}R Documentation

Log transformed cutaneous delivery of econazole (ECZ) from bioequivalent products on porcine skin

Description

Original data were collected in the same way as described in Quariter et. al. (2019), and represents cutaneous delivery of econazole nitrate (ECZ in ng/cm^2) on porcine skin from a reference medicinal product and an approved bioequivalent product. The dataset contains 17 pairs of comparable porcine skin samples on which measurement of ECZ deposition was gathered, and log transformed, using both creams.

Usage

data(skin)

Format

A 'data.frame' with 16 rows and 2 columns:

Reference

Econazole nitrate delivery for the reference product.

Generic

Econazole nitrate delivery for the generic bioequivalent product.

Obs.

The observation corresponds to a given skin on which the log ECZ delivery was collected for each of the reference and generic cream.

References

Quartier, Julie, et al. "Cutaneous Biodistribution: A High-Resolution Methodology to Assess Bioequivalence in Topical Skin Delivery", Pharmaceutics, (2019). Boulaguiem, Younes, et al. "Finite Sample Adjustments for Average Equivalence Testing", bioRxiv, (2023)

Examples

data(skin)
theta <- diff(apply(skin,2,mean))
nu <- nrow(skin)-1
sigma_nu <- sd(apply(skin,1,diff))/sqrt(nu)

[Package cTOST version 1.0.0 Index]