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

ConclusionsThe 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.

http://link.springer.com/10.1007/s13318-017-0459-1

Source: European Journal of Drug Metabolism and Pharmacokinetics - February 5, 2018 Category: Drugs & Pharmacology Source Type: research