TEST METHOD OF BIOAVAILABILITY AND BIOEQUIVALENCE FOR XENOBIOTICS USING GENETIC PROFILING

摘要

A test method of bioavailability or biological equivalence of xenobiotics with genetic information is provided to enhance statistic power of bioavailability or biological equivalence and clearly determine the difference between formulations. A test method of bioavailability or bioequivalence of xenobiotics comprises: a step of screening genotype of metabolic enzyme or transporter which affects pharmacokinetics or pharmacodynamics; a step of confirming whether genotype of the metabolic enzyme or transporter is wild type, heterozygous type or mutant type; and a step of determining test sample.