Genotyping as a Key Element of Sample Size Optimization in Bioequivalence of Risperidone Tablets.

Ying ChenYang DengMiao YanZhenyan HouYao LiBi-Kui ZhangHualin Cai

Published in: European journal of drug metabolism and pharmacokinetics (2018)

The test formulation met the Food and Drug Administration guidelines and regulation criteria for bioequivalence. By controlling the genotype, it could actually help reduce the CVw, which may be a feasible method to decrease the sample size for the bioequivalence study of highly variable drugs.

Keyphrases

drug administration
high throughput
genome wide
tyrosine kinase
gene expression
risk assessment
dna methylation
human health