In Vitro Metabolism Study

In vitro metabolism study characterises drug biotransformation pathways employing liver microsomes or hepatocytes. Microsomal incubation identifies phase I oxidative metabolism. Hepatocyte metabolism includes phases I, II, and III metabolism. Mechanism-of-action identification guides drug-drug interaction prediction. Metabolite characterisation informs structural alerting.

Human hepatocyte metabolism provides superior prediction versus animal models. Regulatory submissions justify metabolism characterisation. Pharmacokinetic predictions support dose selection. Bioanalytical methods detect parent drug and metabolites. Emerging metabolomics unbiasedly identifies unexpected metabolites.