Drug metabolism or more generally, xenobiotic metabolism, is the biotransformation of exogenous compounds by living organisms, usually through specialized enzymatic systems. The metabolism of experimental therapeutics is an important aspect of pharmacology and translational medicine as the rate and the interindividual variability of drug metabolism can determine the duration and/or efficacy of a drug’s pharmacologic action. Since the introduction of metabolites in safety testing guidance by the Food and Drug Administration, major changes have occurred in the experimental methods for the identification and quantification of metabolites, evaluation of metabolites, and the timing of critical nonclinical studies to generate this information.
Part of the book: Drug Metabolism