Ex vivo enzyme induction for metabolic quality investigation
Ex vivo enzyme induction studies are used to determine whether an administered drug induces or enhances the expression of a drug-metabolizing enzyme. These studies are necessary for ensuring efficacious plasma concentrations of a drug, as increased expression of a drug-metabolizing enzyme can increase the metabolic clearance of the drug, thereby reducing its efficacy and therapeutic effect. They can also be used to understand the reason behind unusual toxicokinetic profiles in safety assessment studies. The studies are conducted in liver microsomes of treated animals that have the closest induction profile to humans such as NHPs, canines, rats or mice.