Article
Analytical and biological variation in repeated sweat chloride concentrations in clinical trials for CFTR modulator therapy.
Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society - 1 Jan 2018
LeGrys V A, Moon T C, Laux J, Rock M J, Accurso F
Abstract excerpt
BACKGROUND: Using sweat chloride as a biomarker for CFTR modifying drugs requires knowledge of analytical and biological variation. METHODS: 979 sweat chloride concentrations from 128 subjects enrolled in the placebo arm of 2 multicenter, investigational drug trials were analyzed to determine coefficients of variation (CV) as well as reference change value (RCV) and index of individuality (II). RESULTS: For these...
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