This session will describe opportunities to identify molecular predictors of drug-induced harm in clinical development and postmarketing surveillance. It will outline the potential to predict and assess drug-drug interactions during drug development, based on mathematical models of in vitro and human pharmacokinetic data. In addition, it will present case studies of analytical approaches to discern the molecular basis for reported adverse drug reactions to marketed products and related approaches to de-risking development stage drug candidates, including chemical structures, drug-target affinities, metabolizing enzymes and pathways.