Article
Use of pharmacogenetics in bioequivalence studies to reduce sample size: an example with mirtazapine and CYP2D6.
The pharmacogenomics journal - 1 Oct 2013
González-Vacarezza N, Abad-Santos F, Carcas-Sansuan A, Dorado P, Peñas-Lledó E, Estévez-Carrizo F, Llerena A
Abstract excerpt
In bioequivalence studies, intra-individual variability (CV(w)) is critical in determining sample size. In particular, highly variable drugs may require enrollment of a greater number of subjects. We hypothesize that a strategy to reduce pharmacokinetic CV(w), and hence sample size and costs, would be to include subjects with decreased metabolic enzyme capacity for the drug under study. Therefore, two mirtazapine...
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